xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05996887</url>
    </required_header>
    <id_info>
      <org_study_id>820:6/2023</org_study_id>
      <nct_id>NCT05996887</nct_id>
    </id_info>
    <brief_title>Impact of ERAS on Postoperative Nausea and Vomiting After Sleeve</brief_title>
    <official_title>Impact of Enhanced Recovery After Surgery (ERAS) for Sleeve Gastrectomy on Postoperative Nausea and Vomiting: Controlled Randomized Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Minia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Minia University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The use of bariatric surgery in the treatment of severe obesity has several benefits in terms&#xD;
        of sustainable weight loss, improvements, or resolution of several metabolic comorbidities as&#xD;
        well as improved life expectancy.&#xD;
  &#xD;
        Gastric surgery, history of acid reflux and reduction in gastric size, in particular after&#xD;
        laparoscopic sleeve gastrectomy (LSG), surgery may further contribute to postoperative nausea&#xD;
        and vomiting (PONV).&#xD;
  &#xD;
        The combination of antiemetic drugs that act at different receptors is more effective than&#xD;
        using only one drug in preventing PONV in patients with increased risk for these events.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After obtaining Institutional Ethical Committee approval and written informed consent from&#xD;
        the patients in each case, the ASA score, Simplified Apfel scores14 a measure of PONV risk,&#xD;
        and duration of preoperative fasting are calculated for each patient. Patients will be&#xD;
        randomly allocated into two groups.&#xD;
  &#xD;
        Group 1 (non-ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and&#xD;
        ondansetron 8 mg in addition to standard care protocol.&#xD;
  &#xD;
        Group 2 (ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and&#xD;
        ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.&#xD;
  &#xD;
        All patients will receive general anesthesia. The doses of anesthetic drugs for induction and&#xD;
        maintenance of anesthesia are calculated with reference to the ideal body weight (IBW) and&#xD;
        the corrected body weight (CBW) in patients, where IBW=height (in cm)-100 for men and height&#xD;
        (in cm)-105 for women and CBW=IBW+ [0.4 × (current weight-ideal weight)]12.&#xD;
  &#xD;
        Anesthesia and Operative Technique for Non-ERAS:&#xD;
  &#xD;
          1. Anesthesia:&#xD;
  &#xD;
             Induction of anesthesia IS carried out with propofol 2 mg kg -1 iv of CBW, fentanyl 3 μg&#xD;
             kg-1 CBW, and cisatracurium 0.1 mg kg-1 iv of IBW for tracheal intubation. The&#xD;
             maintenance IS performed with fentanyl 0.1 to 0.3 μg kg-1 min -1 iv of IBW, isoflurane 1&#xD;
             % mixture of oxygen and air 1:1, and an additional dose of cisatracurium if necessary.&#xD;
             Neuromuscular blockade IS reversed with neostigmine up to 0.04 mg kg-1 IV of IBW and&#xD;
             atropine up to 0.015 mg kg-1 iv of IBW.&#xD;
  &#xD;
          2. Antiemetic protocol:&#xD;
  &#xD;
               -  Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia.&#xD;
  &#xD;
               -  Haloperidol 2 mg after induction of anesthesia and ondansetron 8 mg IS infused 20&#xD;
                  to 30 min prior to the end of the operation.&#xD;
  &#xD;
          3. Postoperative Analgesia Analgesia IS done with intravenous ketorolac 30 mg immediately&#xD;
             after the induction of anesthesia and maintained at 8 h and acetaminophen IV 1 g every 6&#xD;
             h. IS used in the PACU to keep PVRS&lt;4. Patient-controlled analgesia (PCA) containing 20&#xD;
             mg Nalbuphine (Nalbuphine HCl 20mg / 1ml) to 100 ml with normal saline over 24 hours.&#xD;
             The PCA infuser unit IS infused at a rate of 2 ml.h-1 with a lockout time of 15 min &amp;&#xD;
             bolus of 1 ml per time. The intensity of pain IS measured by a pain verbal rating scale&#xD;
             (PVRS, 0=no pain to 10=worst pain)12.&#xD;
  &#xD;
        Anesthesia and Operative Technique for ERAS:&#xD;
  &#xD;
        The institutional ERAS is described in Table 1. Table 1: Technique for ERAS15,16.&#xD;
        Preoperative protocols&#xD;
  &#xD;
        Pain management • Acetaminophen 1000mg PO 2h before anesthesia&#xD;
  &#xD;
          -  Gabapentin 400 ml PO before anesthesia Diet • Clear liquids until 3 h prior to surgery&#xD;
             PONV prevention • H2 receptor antagonist&#xD;
  &#xD;
          -  Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia Preoperative&#xD;
             fasting&#xD;
  &#xD;
          -  Fasting to solids until 6 h before induction and clear liquids until 2 h before&#xD;
             induction.&#xD;
  &#xD;
        Intraoperative protocols&#xD;
  &#xD;
        Anesthesia General anesthesia: TIVA16,17&#xD;
  &#xD;
          -  Propofol (2 mg kg-1 iv of CBW). GA IS maintained with i.v. infusion of propofol (75-150&#xD;
             mg kg-1 min-1).&#xD;
  &#xD;
          -  Dexmedetomidine (0.5 mg kg-1 i.v. over 10 min) IS initiated and maintained with an i.v.&#xD;
             infusion of dexmedetomidine (0.1-0.3 mg kg-1h-1).&#xD;
  &#xD;
          -  Ketamine a single dose before incision (0.5 mg kg-1 i.v.) then 0.5 mg.kg-1.h-1.&#xD;
  &#xD;
          -  Muscle relaxation with cisatracurium 0.1 mg kg-1 iv of IBW IS maintained with boluses&#xD;
             additional dose of cisatracurium if necessary. Neuromuscular blockade IS reversed with&#xD;
             neostigmine up to 0.04 mg kg-1 IV of IBW and atropine up to 0.015 mg kg-1 iv of IBW.&#xD;
  &#xD;
          -  Patients are ventilated with a mixture of oxygen and air. At the end of the surgery,&#xD;
             muscle relaxation IS reversed with neostigmine (up to 5 mg) and glycopyrrolate (0.2-0.8&#xD;
             mg).&#xD;
  &#xD;
        Antiemetic protocol: • Haloperidol 2mg IS administered immediately after induction of&#xD;
        anesthesia and ondansetron IS infused 20 to 30 min prior to the end of the operation.&#xD;
  &#xD;
        Pain management • Lidocaine 1 mg kg, then by 1 mg kg-1 hr-1. continuous infusion 1 mg. kg&#xD;
        -1h-1. for maintenance.&#xD;
  &#xD;
          -  Magnesium Sulfate (30 mg/kg) + continuous infusion (10 mg/kg/h)&#xD;
  &#xD;
          -  Bilateral Transversus Abdominis plane block (TAP) at the end of the operation. Fluid&#xD;
             management • Goal-directed IV fluid therapy, avoiding both restrictive or liberal&#xD;
             strategies.&#xD;
  &#xD;
        Abdominal drainage and nasogastric decompression • Nasogastric tubes and abdominal drains&#xD;
        should not be used Postoperative protocols Pain management • Bilateral Transversus Abdominis&#xD;
        plane block (TAP) at the end of the operation.&#xD;
  &#xD;
          -  Lidocaine IV drip for 24 h&#xD;
  &#xD;
          -  Acetaminophen IV transitioned to PO.&#xD;
  &#xD;
          -  Ketoralac 30 mg every 8 h&#xD;
  &#xD;
          -  acetaminophen IV 1 g every 6 h.&#xD;
  &#xD;
          -  IV Nalbuphine, breakthrough pain. The intensity of pain IS measured by a pain verbal&#xD;
             rating scale (PVRS, 0=no pain to 10=worst pain)&#xD;
  &#xD;
        PONV treatment • Ondansetron 8 mg IS used as the primary rescue antiemetic and metoclopramide&#xD;
        10 mg IV IS utilized in PONV refractory to ondansetron.&#xD;
  &#xD;
        Thromboprophylaxis&#xD;
  &#xD;
          -  Thromboprophylaxis should involve mechanical and pharmacological measures. Doses and&#xD;
             duration of treatment should be individualized.&#xD;
  &#xD;
        Fluid management • Stop IV fluids on POD 1 Early postoperative nutritional care • Stop IV&#xD;
        fluids on POD 1&#xD;
  &#xD;
        • Clear liquids on POD 0 PO: Per oral, PONV: postoperative nausea and vomiting, IV:&#xD;
        intravenous, prn: when required, POD: postoperative day.&#xD;
  &#xD;
        Postoperative Care for both groups:&#xD;
  &#xD;
          1. Feeding A liquid diet IS prescribed for the first postoperative day, followed by a diet&#xD;
             containing broth without residue as tolerated by the patient.&#xD;
  &#xD;
          2. Rescue Antiemetic The PONV IS defined as at least one episode of nau¬sea, vomiting, or&#xD;
             retching. PONV IS evaluated as follows: I = no nausea or vomiting, II = nausea but no&#xD;
             vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more&#xD;
             than five times within 24h.&#xD;
  &#xD;
             The severity of postoperative nausea (PON) IS assessed using a numeric rating scale (I =&#xD;
             mild, II = mod¬erate, III = severe).&#xD;
  &#xD;
             The severity of postoperative vomiting (POV) IS recorded according to the number of&#xD;
             vomiting episodes (I = no vomiting, II = vomiting episodes occurring 1-2 times within 24&#xD;
             h, III = vomiting episodes occurring 3-5 times within 24 h, IV = vomiting episodes&#xD;
             occurring more than 5 times within 24 h). The volume of postoperative water intake IS&#xD;
             measured during the two periods (0-24 h and 24-36h). Nausea IS assessed hourly during&#xD;
             the first two hours, every two hours for the following four hours, and every four hours&#xD;
             until the 24th hour. Nausea IS evaluated on a three-point scale from 0 (no nausea), 1&#xD;
             (mild nausea) to 2 (severe nausea). A patient IS classified to have had PONV if any&#xD;
             nausea and/or vomiting occurred within the first 24 postoperative hours.&#xD;
  &#xD;
             The patient IS given ondansetron IV as the primary rescue antiemetic and metoclopramide&#xD;
             10 mg IV IS utilized in PONV refractory to ondansetron, when there IS an episode of&#xD;
             vomiting or if there IS a request at any time made by the patient for treatment of&#xD;
             symptoms.&#xD;
  &#xD;
          3. Outcome Variables Secondary endpoints included time to first administration of rescue&#xD;
             antiemetic drug, the number of rescues, postoperative opioid consumption, time to&#xD;
             tolerate oral fluid, and time to readiness for discharge. Data collection IS done by&#xD;
             blinded personnel at the end of the following postoperative time intervals: 0-2, 2-12,&#xD;
             12-24, and 24-36 h, postoperatively. The quality of recovery IS assessed by QoR-1518&#xD;
             questionnaires at discharge. In patients who are discharged before 36 h, the&#xD;
             questionnaires are filled out during a telephone call the next morning.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 30, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of postoperative nausea and vomiting</measure>
      <time_frame>36 hours</time_frame>
      <description>number and percentage of episode of nausea and vomiting&#xD;
  : I = no nausea or vomiting, II = nausea but no vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more than five times within 24h.&#xD;
  The severity of postoperative nausea (PON) was assessed using a numeric rating scale (I = mild, II = mod¬erate, III = severe).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to first administration of rescue antiemetic drug.</measure>
      <time_frame>36 hours</time_frame>
      <description>Time in minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative opioid consumption.</measure>
      <time_frame>36 hours</time_frame>
      <description>amount in ml of opioid given in the 36 hours after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to tolerate oral fluid</measure>
      <time_frame>36 hours</time_frame>
      <description>time in minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The quality of recovery.</measure>
      <time_frame>36 hours</time_frame>
      <description>questionnaire: QoR 15 patient survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complications.</measure>
      <time_frame>36 hours</time_frame>
      <description>number and percentage of complication related to technique of TAP as hematoma formation at the injection site, vascular or lymphatic injury, neurologic symptoms and local anesthetic toxicity</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Nausea and Vomiting, Postoperative</condition>
    <arm_group>
      <arm_group_label>non- enhanced recovery after surgery</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>enhanced recovery after surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg, and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>standard care protcol</intervention_name>
      <description>All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.</description>
      <arm_group_label>non- enhanced recovery after surgery</arm_group_label>
      <other_name>control</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>enhanced recovery protocol</intervention_name>
      <description>All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.</description>
      <arm_group_label>enhanced recovery after surgery</arm_group_label>
      <other_name>ERAC</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          * Age: 18-60 years&#xD;
  &#xD;
            -  Sex: Both sex&#xD;
  &#xD;
            -  ASA Physical Status: II, III.&#xD;
  &#xD;
            -  Body mass index: Between 40 and 60 kg/m2.&#xD;
  &#xD;
            -  Participants: Patients who are undergoing elective Sleeve Gastrectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with hypersensitivity or contraindication to haloperidol, dexamethasone, or&#xD;
               ondansetron.&#xD;
  &#xD;
            -  Serious complications in the perioperative period (such as shock, cardiac arrest,&#xD;
               hemorrhage, needing transfusion).&#xD;
  &#xD;
            -  Psychiatric disorder.&#xD;
  &#xD;
            -  History of migraine.&#xD;
  &#xD;
            -  Use of opioid, hormonal, anti-inflammatory, and antiemetic medication 24 h prior to&#xD;
               surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>haidy S mansour, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>haidy s mansour, MD</last_name>
      <phone>1221802324</phone>
      <phone_ext>0020</phone_ext>
      <email>haidy_mourad@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>hassan M hetta, MD</last_name>
      <phone>1010901114</phone>
      <phone_ext>0020</phone_ext>
      <email>hassan.hetta@mu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Minia University</name>
        <address>
          <city>Minya</city>
          <state>Minia</state>
          <zip>61511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>haidy s mansour, ass prof</last_name>
        <phone>1221802324</phone>
        <phone_ext>0020</phone_ext>
        <email>Hassan.Hetta@mu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>hassan M hetta, lecturer</last_name>
        <phone>1010901114</phone>
        <phone_ext>0020</phone_ext>
        <email>hassan.hetta@mu.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Minia University</investigator_affiliation>
      <investigator_full_name>haidy salah mansour</investigator_full_name>
      <investigator_title>assistant professor of anesthesia and ICU</investigator_title>
    </responsible_party>
    <keyword>sleeve gastrectomy</keyword>
    <keyword>nausea</keyword>
    <keyword>vomiting</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05996887
  org study id: 820:6/2023
  nct id: NCT05996887
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The use of bariatric surgery in the treatment of severe obesity has several benefits in terms
        of sustainable weight loss, improvements, or resolution of several metabolic comorbidities as
        well as improved life expectancy.
  
        Gastric surgery, history of acid reflux and reduction in gastric size, in particular after
        laparoscopic sleeve gastrectomy (LSG), surgery may further contribute to postoperative nausea
        and vomiting (PONV).
  
        The combination of antiemetic drugs that act at different receptors is more effective than
        using only one drug in preventing PONV in patients with increased risk for these events.
  After obtaining Institutional Ethical Committee approval and written informed consent from
        the patients in each case, the ASA score, Simplified Apfel scores14 a measure of PONV risk,
        and duration of preoperative fasting are calculated for each patient. Patients will be
        randomly allocated into two groups.
  
        Group 1 (non-ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and
        ondansetron 8 mg in addition to standard care protocol.
  
        Group 2 (ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and
        ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.
  
        All patients will receive general anesthesia. The doses of anesthetic drugs for induction and
        maintenance of anesthesia are calculated with reference to the ideal body weight (IBW) and
        the corrected body weight (CBW) in patients, where IBW=height (in cm)-100 for men and height
        (in cm)-105 for women and CBW=IBW+ [0.4 × (current weight-ideal weight)]12.
  
        Anesthesia and Operative Technique for Non-ERAS:
  
          1. Anesthesia:
  
             Induction of anesthesia IS carried out with propofol 2 mg kg -1 iv of CBW, fentanyl 3 μg
             kg-1 CBW, and cisatracurium 0.1 mg kg-1 iv of IBW for tracheal intubation. The
             maintenance IS performed with fentanyl 0.1 to 0.3 μg kg-1 min -1 iv of IBW, isoflurane 1
             % mixture of oxygen and air 1:1, and an additional dose of cisatracurium if necessary.
             Neuromuscular blockade IS reversed with neostigmine up to 0.04 mg kg-1 IV of IBW and
             atropine up to 0.015 mg kg-1 iv of IBW.
  
          2. Antiemetic protocol:
  
               -  Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia.
  
               -  Haloperidol 2 mg after induction of anesthesia and ondansetron 8 mg IS infused 20
                  to 30 min prior to the end of the operation.
  
          3. Postoperative Analgesia Analgesia IS done with intravenous ketorolac 30 mg immediately
             after the induction of anesthesia and maintained at 8 h and acetaminophen IV 1 g every 6
             h. IS used in the PACU to keep PVRS<4. Patient-controlled analgesia (PCA) containing 20
             mg Nalbuphine (Nalbuphine HCl 20mg / 1ml) to 100 ml with normal saline over 24 hours.
             The PCA infuser unit IS infused at a rate of 2 ml.h-1 with a lockout time of 15 min &
             bolus of 1 ml per time. The intensity of pain IS measured by a pain verbal rating scale
             (PVRS, 0=no pain to 10=worst pain)12.
  
        Anesthesia and Operative Technique for ERAS:
  
        The institutional ERAS is described in Table 1. Table 1: Technique for ERAS15,16.
        Preoperative protocols
  
        Pain management • Acetaminophen 1000mg PO 2h before anesthesia
  
          -  Gabapentin 400 ml PO before anesthesia Diet • Clear liquids until 3 h prior to surgery
             PONV prevention • H2 receptor antagonist
  
          -  Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia Preoperative
             fasting
  
          -  Fasting to solids until 6 h before induction and clear liquids until 2 h before
             induction.
  
        Intraoperative protocols
  
        Anesthesia General anesthesia: TIVA16,17
  
          -  Propofol (2 mg kg-1 iv of CBW). GA IS maintained with i.v. infusion of propofol (75-150
             mg kg-1 min-1).
  
          -  Dexmedetomidine (0.5 mg kg-1 i.v. over 10 min) IS initiated and maintained with an i.v.
             infusion of dexmedetomidine (0.1-0.3 mg kg-1h-1).
  
          -  Ketamine a single dose before incision (0.5 mg kg-1 i.v.) then 0.5 mg.kg-1.h-1.
  
          -  Muscle relaxation with cisatracurium 0.1 mg kg-1 iv of IBW IS maintained with boluses
             additional dose of cisatracurium if necessary. Neuromuscular blockade IS reversed with
             neostigmine up to 0.04 mg kg-1 IV of IBW and atropine up to 0.015 mg kg-1 iv of IBW.
  
          -  Patients are ventilated with a mixture of oxygen and air. At the end of the surgery,
             muscle relaxation IS reversed with neostigmine (up to 5 mg) and glycopyrrolate (0.2-0.8
             mg).
  
        Antiemetic protocol: • Haloperidol 2mg IS administered immediately after induction of
        anesthesia and ondansetron IS infused 20 to 30 min prior to the end of the operation.
  
        Pain management • Lidocaine 1 mg kg, then by 1 mg kg-1 hr-1. continuous infusion 1 mg. kg
        -1h-1. for maintenance.
  
          -  Magnesium Sulfate (30 mg/kg) + continuous infusion (10 mg/kg/h)
  
          -  Bilateral Transversus Abdominis plane block (TAP) at the end of the operation. Fluid
             management • Goal-directed IV fluid therapy, avoiding both restrictive or liberal
             strategies.
  
        Abdominal drainage and nasogastric decompression • Nasogastric tubes and abdominal drains
        should not be used Postoperative protocols Pain management • Bilateral Transversus Abdominis
        plane block (TAP) at the end of the operation.
  
          -  Lidocaine IV drip for 24 h
  
          -  Acetaminophen IV transitioned to PO.
  
          -  Ketoralac 30 mg every 8 h
  
          -  acetaminophen IV 1 g every 6 h.
  
          -  IV Nalbuphine, breakthrough pain. The intensity of pain IS measured by a pain verbal
             rating scale (PVRS, 0=no pain to 10=worst pain)
  
        PONV treatment • Ondansetron 8 mg IS used as the primary rescue antiemetic and metoclopramide
        10 mg IV IS utilized in PONV refractory to ondansetron.
  
        Thromboprophylaxis
  
          -  Thromboprophylaxis should involve mechanical and pharmacological measures. Doses and
             duration of treatment should be individualized.
  
        Fluid management • Stop IV fluids on POD 1 Early postoperative nutritional care • Stop IV
        fluids on POD 1
  
        • Clear liquids on POD 0 PO: Per oral, PONV: postoperative nausea and vomiting, IV:
        intravenous, prn: when required, POD: postoperative day.
  
        Postoperative Care for both groups:
  
          1. Feeding A liquid diet IS prescribed for the first postoperative day, followed by a diet
             containing broth without residue as tolerated by the patient.
  
          2. Rescue Antiemetic The PONV IS defined as at least one episode of nau¬sea, vomiting, or
             retching. PONV IS evaluated as follows: I = no nausea or vomiting, II = nausea but no
             vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more
             than five times within 24h.
  
             The severity of postoperative nausea (PON) IS assessed using a numeric rating scale (I =
             mild, II = mod¬erate, III = severe).
  
             The severity of postoperative vomiting (POV) IS recorded according to the number of
             vomiting episodes (I = no vomiting, II = vomiting episodes occurring 1-2 times within 24
             h, III = vomiting episodes occurring 3-5 times within 24 h, IV = vomiting episodes
             occurring more than 5 times within 24 h). The volume of postoperative water intake IS
             measured during the two periods (0-24 h and 24-36h). Nausea IS assessed hourly during
             the first two hours, every two hours for the following four hours, and every four hours
             until the 24th hour. Nausea IS evaluated on a three-point scale from 0 (no nausea), 1
             (mild nausea) to 2 (severe nausea). A patient IS classified to have had PONV if any
             nausea and/or vomiting occurred within the first 24 postoperative hours.
  
             The patient IS given ondansetron IV as the primary rescue antiemetic and metoclopramide
             10 mg IV IS utilized in PONV refractory to ondansetron, when there IS an episode of
             vomiting or if there IS a request at any time made by the patient for treatment of
             symptoms.
  
          3. Outcome Variables Secondary endpoints included time to first administration of rescue
             antiemetic drug, the number of rescues, postoperative opioid consumption, time to
             tolerate oral fluid, and time to readiness for discharge. Data collection IS done by
             blinded personnel at the end of the following postoperative time intervals: 0-2, 2-12,
             12-24, and 24-36 h, postoperatively. The quality of recovery IS assessed by QoR-1518
             questionnaires at discharge. In patients who are discharged before 36 h, the
             questionnaires are filled out during a telephone call the next morning.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: The incidence of postoperative nausea and vomiting
  time frame: 36 hours
  description: number and percentage of episode of nausea and vomiting
  : I = no nausea or vomiting, II = nausea but no vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more than five times within 24h.
  The severity of postoperative nausea (PON) was assessed using a numeric rating scale (I = mild, II = mod¬erate, III = severe).
  measure: Time to first administration of rescue antiemetic drug.
  time frame: 36 hours
  description: Time in minute
  measure: postoperative opioid consumption.
  time frame: 36 hours
  description: amount in ml of opioid given in the 36 hours after surgery
  measure: Time to tolerate oral fluid
  time frame: 36 hours
  description: time in minute
  measure: The quality of recovery.
  time frame: 36 hours
  description: questionnaire: QoR 15 patient survey
  measure: complications.
  time frame: 36 hours
  description: number and percentage of complication related to technique of TAP as hematoma formation at the injection site, vascular or lymphatic injury, neurologic symptoms and local anesthetic toxicity
  arm group label: non- enhanced recovery after surgery
  arm group type: Placebo Comparator
  description: All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.
  arm group label: enhanced recovery after surgery
  arm group type: Active Comparator
  description: All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg, and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.
  intervention type: Other
  intervention name: standard care protcol
  description: All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.
  arm group label: non- enhanced recovery after surgery
  other name: control
  intervention type: Other
  intervention name: enhanced recovery protocol
  description: All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.
  arm group label: enhanced recovery after surgery
  other name: ERAC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: haidy S mansour, MD
  role: Principal Investigator
  affiliation: Assistant professor
  last name: haidy s mansour, MD
  phone: 1221802324
  phone ext: 0020
  email: haidy_mourad@yahoo.com
  last name: hassan M hetta, MD
  phone: 1010901114
  phone ext: 0020
  email: hassan.hetta@mu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Minia University
  investigator full name: haidy salah mansour
  investigator title: assistant professor of anesthesia and ICU
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Postoperative Nausea and Vomiting
  sharing ipd: No