<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/NCT03029715</url>
  </required_header>
  <id_info>
    <org_study_id>MenoufiaU2016/2</org_study_id>
    <nct_id>NCT03029715</nct_id>
  </id_info>
  <brief_title>Anaesthesia for Laparoscopic Sleeve Gastrectomy</brief_title>
  <official_title>Comparative Study Between Inhalational Anaesthesia and Total Intravenous Anaesthesia (TIVA) With Dexmedetomidine for Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous&#xD;
      anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is&#xD;
      still unclear which anaesthesia regimen is better for this group of patients. The present&#xD;
      study was carried out to compare the use of inhalation anaesthesia technique using desflurane&#xD;
      and TIVA using propofol and dexmedetomidine.&#xD;
&#xD;
      Methods: This randomized controlled trial was carried out on 100 morbidly obese patients&#xD;
      undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal&#xD;
      groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received&#xD;
      general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation&#xD;
      group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group&#xD;
      anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion.&#xD;
      Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative&#xD;
      nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and&#xD;
      post-anaesthetic care unit (PACU) stay were studied for both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining the ethics committee approval of El Menoufia University hospital and the&#xD;
      informed written consent from the patients, a hundred morbidly obese patients scheduled for&#xD;
      sleeve gastrectomy were recruited for the study. Patients with history of cardiac&#xD;
      comorbidity, chronic obstructive lung disease, drug abuse, expected difficult intubation&#xD;
      patients, and patients with history of allergy to the study drugs were excluded from the&#xD;
      study. Patients from 30 to 50 years old of both sexes were randomly allocated using&#xD;
      computerized software into two groups, fifty patients in each group. Patients in inhalation&#xD;
      group received intra-operative inhalational anaesthetic while patients in TIVA group received&#xD;
      TIVA for anaesthetic maintenance.&#xD;
&#xD;
      All patients received a routine premedication with oral sodium citrate 15ml [0.3 molar&#xD;
      (1.16gm)] and intravenous (IV) 4mg ondansetron fifteen minutes before induction. Patients in&#xD;
      both groups were connected to the routine monitoring and bispectral index (BIS) upon arrival&#xD;
      to theatre. Anaesthesia induction for both groups was carried out by 0.5-1 mcg kg -1&#xD;
      remifentanil, 2-3mg kg-1 propofol, and 0.6 mg kg-1 rocuronium. Endotracheal intubation was&#xD;
      done with the appropriate tube size.&#xD;
&#xD;
      In the inhalational group, anaesthesia was maintained by desflurane in low flow oxygen air&#xD;
      mixture 60/40%. In the TIVA group, anaesthesia was maintained using propofol 8-12 mg kg-1 h-1&#xD;
      and dexmedetomidine 0.5-1ugkg-1h-1. Remifentanil infusion of 0.05-2 µg kg-¹min-¹ was&#xD;
      administered for both groups. Muscle relaxation was maintained in both groups by rocuronium&#xD;
      infusion at a rate of 10-12ug kg1min-1. Depth of anaesthesia was monitored by bispectral&#xD;
      index and anaesthetics were adjusted in both groups to obtain BIS of 40 to 60 by giving&#xD;
      boluses of 0.5ug kg-1 remifentanil. The total boluses of intra-operative remifentanil were&#xD;
      recorded. At the end of the procedure all patients received 0.6mg atropine and sugammadex&#xD;
      16mg kg-1 to reverse the effect of rocuronium. Patients were extubated and transferred to the&#xD;
      post-anaesthetic care unit (PACU).&#xD;
&#xD;
      Post-operative pain was monitored using visual analogue score (VAS) at PACU. Morphine&#xD;
      sulphate 2 to 3 mg was given if the VAS was &gt; 4. Intravenous paracetamol 1gm and/or ketorolac&#xD;
      30 mg were given eight hourly intravenously if needed (VAS ≥3). Post-operative ondansetron&#xD;
      4mg every eight hours was given if required.&#xD;
&#xD;
      Haemodynamics including heart rate and mean arterial blood pressure (MABP) were recorded as a&#xD;
      baseline and every fifteen minutes intra-operatively. Recovery time from anaesthesia using&#xD;
      Aldrete score was recorded (the time from cessation of all anesthetics until complete&#xD;
      recovery). 10 The incidence of post-operative nausea and vomiting, post-operative analgesic&#xD;
      requirements, and the duration of PACU stay were recorded. Post-operative pain assessment&#xD;
      using VAS from 0 to 10, where 0 means no pain and 10 is the worst pain the patient&#xD;
      experienced. VAS was recorded at full recovery, every 15 minutes in PACU until discharge&#xD;
      PACU. Time of onset of post-operative bowel movement was recorded.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Sample size calculation was calculated using Graphed Instant statistics version 3. Based on&#xD;
      the previous, studies propofol was expected to produce a drop in the MABP after induction of&#xD;
      anaesthesia by about 10 mmHg with a standard deviation of 15 mmHg so by choosing level of&#xD;
      significance 0.05 and power of 90%; the calculated sample size was 48 patients so that the&#xD;
      number of patients randomized in each group was fifty patients to ensure reliable results.&#xD;
&#xD;
      Statistical analysis was done using SPSS 19 (SPSS Inc, IBM company, Chicago,USA). The&#xD;
      patients' sex, American society of anaesthetists (ASA) status and incidence of side effects&#xD;
      were analyzed using the chi-square χ2-test. Other parameters were compared using student&#xD;
      t-test. For comparisons within the same group, paired t-test was used where for comparisons&#xD;
      between groups; unpaired t-test was used. P-value less than 0.05 was considered statistically&#xD;
      significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic Requirements.</measure>
    <time_frame>Within one hour after surgery</time_frame>
    <description>Total paracetamol consumption.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Intra-operative Mean Arterial Blood Pressure.</measure>
    <time_frame>During operation and follow-up, an average of 2 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>Intravenous anaesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Propofol Dexmedetomidine Remifentanil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inhalation anaesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Desflurane Remifentanil</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Total intravenous anaesthesia.</description>
    <arm_group_label>Intravenous anaesthesia</arm_group_label>
    <other_name>TIVA group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Narcotics</description>
    <arm_group_label>Inhalation anaesthesia</arm_group_label>
    <arm_group_label>Intravenous anaesthesia</arm_group_label>
    <other_name>TIVA group and inhalation group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Total intravenous anaesthesia</description>
    <arm_group_label>Intravenous anaesthesia</arm_group_label>
    <other_name>TIVA group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>Inhalation anaesthesia.</description>
    <arm_group_label>Inhalation anaesthesia</arm_group_label>
    <other_name>Inhalation group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbid obese scheduled for sleeve gastrectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusal and allergy to drugs used.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>August 10, 2020</results_first_submitted>
  <results_first_submitted_qc>August 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2020</results_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Dr Ezzeldin Ibrahim</investigator_full_name>
    <investigator_title>Assistant Professor in anaesthesia, intensive care, and pain medicine.</investigator_title>
  </responsible_party>
  <keyword>Sleeve gastrectomy</keyword>
  <keyword>TIVA</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intravenous Anaesthesia</title>
          <description>Propofol Dexmedetomidine Remifentanil&#xD;
Propofol: Total intravenous anaesthesia.&#xD;
Remifentanil: Narcotics&#xD;
Dexmedetomidine: Total intravenous anaesthesia</description>
        </group>
        <group group_id="P2">
          <title>Inhalation Anaesthesia</title>
          <description>Desflurane Remifentanil&#xD;
Remifentanil: Narcotics&#xD;
Desflurane: Inhalation anaesthesia.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intravenous Anaesthesia</title>
          <description>Propofol Dexmedetomidine Remifentanil&#xD;
Propofol: Total intravenous anaesthesia.&#xD;
Remifentanil: Narcotics&#xD;
Dexmedetomidine: Total intravenous anaesthesia</description>
        </group>
        <group group_id="B2">
          <title>Inhalation Anaesthesia</title>
          <description>Desflurane Remifentanil&#xD;
Remifentanil: Narcotics&#xD;
Desflurane: Inhalation anaesthesia.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.31" spread="10.43"/>
                    <measurement group_id="B2" value="34.35" spread="11.15"/>
                    <measurement group_id="B3" value="34.83" spread="10.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Egypt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Analgesic Requirements.</title>
        <description>Total paracetamol consumption.</description>
        <time_frame>Within one hour after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sleeve Gastrectomy 1</title>
            <description>Propofol Dexmedetomidine Remifentanil&#xD;
Propofol: Total intravenous anaesthesia.&#xD;
Remifentanil: Narcotics&#xD;
Dexmedetomidine: Total intravenous anaesthesia</description>
          </group>
          <group group_id="O2">
            <title>Sleeve Gastrectomy 2</title>
            <description>Desflurane Remifentanil&#xD;
Remifentanil: Narcotics&#xD;
Desflurane: Inhalation anaesthesia.</description>
          </group>
        </group_list>
        <measure>
          <title>Analgesic Requirements.</title>
          <description>Total paracetamol consumption.</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" spread="1.01"/>
                    <measurement group_id="O2" value="1.67" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Intra-operative Mean Arterial Blood Pressure.</title>
        <time_frame>During operation and follow-up, an average of 2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sleeve Gastrectomy 1</title>
            <description>Propofol Dexmedetomidine Remifentanil&#xD;
Propofol: Total intravenous anaesthesia.&#xD;
Remifentanil: Narcotics&#xD;
Dexmedetomidine: Total intravenous anaesthesia</description>
          </group>
          <group group_id="O2">
            <title>Sleeve Gastrectomy 2</title>
            <description>Desflurane Remifentanil&#xD;
Remifentanil: Narcotics&#xD;
Desflurane: Inhalation anaesthesia.</description>
          </group>
        </group_list>
        <measure>
          <title>The Intra-operative Mean Arterial Blood Pressure.</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.05" spread="3.06"/>
                    <measurement group_id="O2" value="62.7" spread="2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During operation and follow-up, an average of 2 hours</time_frame>
      <desc>Nausea and vomiting</desc>
      <group_list>
        <group group_id="E1">
          <title>Intravenous Anaesthesia</title>
          <description>Propofol Dexmedetomidine Remifentanil&#xD;
Propofol: Total intravenous anaesthesia.&#xD;
Remifentanil: Narcotics&#xD;
Dexmedetomidine: Total intravenous anaesthesia</description>
        </group>
        <group group_id="E2">
          <title>Inhalation Anaesthesia</title>
          <description>Desflurane Remifentanil&#xD;
Remifentanil: Narcotics&#xD;
Desflurane: Inhalation anaesthesia.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Ezzeldin Ibrahim</name_or_title>
      <organization>Menoufia Univeristy</organization>
      <phone>0021006303178</phone>
      <email>ezzeldin7@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT03029715
org study id: MenoufiaU2016/2
nct id: NCT03029715
lead sponsor: 
has dmc: No
Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous
      anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is
      still unclear which anaesthesia regimen is better for this group of patients. The present
      study was carried out to compare the use of inhalation anaesthesia technique using desflurane
      and TIVA using propofol and dexmedetomidine.

      Methods: This randomized controlled trial was carried out on 100 morbidly obese patients
      undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal
      groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received
      general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation
      group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group
      anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion.
      Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative
      nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and
      post-anaesthetic care unit (PACU) stay were studied for both groups.
After obtaining the ethics committee approval of El Menoufia University hospital and the
      informed written consent from the patients, a hundred morbidly obese patients scheduled for
      sleeve gastrectomy were recruited for the study. Patients with history of cardiac
      comorbidity, chronic obstructive lung disease, drug abuse, expected difficult intubation
      patients, and patients with history of allergy to the study drugs were excluded from the
      study. Patients from 30 to 50 years old of both sexes were randomly allocated using
      computerized software into two groups, fifty patients in each group. Patients in inhalation
      group received intra-operative inhalational anaesthetic while patients in TIVA group received
      TIVA for anaesthetic maintenance.

      All patients received a routine premedication with oral sodium citrate 15ml [0.3 molar
      (1.16gm)] and intravenous (IV) 4mg ondansetron fifteen minutes before induction. Patients in
      both groups were connected to the routine monitoring and bispectral index (BIS) upon arrival
      to theatre. Anaesthesia induction for both groups was carried out by 0.5-1 mcg kg -1
      remifentanil, 2-3mg kg-1 propofol, and 0.6 mg kg-1 rocuronium. Endotracheal intubation was
      done with the appropriate tube size.

      In the inhalational group, anaesthesia was maintained by desflurane in low flow oxygen air
      mixture 60/40%. In the TIVA group, anaesthesia was maintained using propofol 8-12 mg kg-1 h-1
      and dexmedetomidine 0.5-1ugkg-1h-1. Remifentanil infusion of 0.05-2 µg kg-¹min-¹ was
      administered for both groups. Muscle relaxation was maintained in both groups by rocuronium
      infusion at a rate of 10-12ug kg1min-1. Depth of anaesthesia was monitored by bispectral
      index and anaesthetics were adjusted in both groups to obtain BIS of 40 to 60 by giving
      boluses of 0.5ug kg-1 remifentanil. The total boluses of intra-operative remifentanil were
      recorded. At the end of the procedure all patients received 0.6mg atropine and sugammadex
      16mg kg-1 to reverse the effect of rocuronium. Patients were extubated and transferred to the
      post-anaesthetic care unit (PACU).

      Post-operative pain was monitored using visual analogue score (VAS) at PACU. Morphine
      sulphate 2 to 3 mg was given if the VAS was > 4. Intravenous paracetamol 1gm and/or ketorolac
      30 mg were given eight hourly intravenously if needed (VAS ≥3). Post-operative ondansetron
      4mg every eight hours was given if required.

      Haemodynamics including heart rate and mean arterial blood pressure (MABP) were recorded as a
      baseline and every fifteen minutes intra-operatively. Recovery time from anaesthesia using
      Aldrete score was recorded (the time from cessation of all anesthetics until complete
      recovery). 10 The incidence of post-operative nausea and vomiting, post-operative analgesic
      requirements, and the duration of PACU stay were recorded. Post-operative pain assessment
      using VAS from 0 to 10, where 0 means no pain and 10 is the worst pain the patient
      experienced. VAS was recorded at full recovery, every 15 minutes in PACU until discharge
      PACU. Time of onset of post-operative bowel movement was recorded.

      Statistical analysis:

      Sample size calculation was calculated using Graphed Instant statistics version 3. Based on
      the previous, studies propofol was expected to produce a drop in the MABP after induction of
      anaesthesia by about 10 mmHg with a standard deviation of 15 mmHg so by choosing level of
      significance 0.05 and power of 90%; the calculated sample size was 48 patients so that the
      number of patients randomized in each group was fifty patients to ensure reliable results.

      Statistical analysis was done using SPSS 19 (SPSS Inc, IBM company, Chicago,USA). The
      patients' sex, American society of anaesthetists (ASA) status and incidence of side effects
      were analyzed using the chi-square χ2-test. Other parameters were compared using student
      t-test. For comparisons within the same group, paired t-test was used where for comparisons
      between groups; unpaired t-test was used. P-value less than 0.05 was considered statistically
      significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Analgesic Requirements.
time frame: Within one hour after surgery
description: Total paracetamol consumption.
measure: The Intra-operative Mean Arterial Blood Pressure.
time frame: During operation and follow-up, an average of 2 hours
arm group label: Intravenous anaesthesia
arm group type: Other
description: Propofol Dexmedetomidine Remifentanil
arm group label: Inhalation anaesthesia
arm group type: Other
description: Desflurane Remifentanil
intervention type: Drug
intervention name: Propofol
description: Total intravenous anaesthesia.
arm group label: Intravenous anaesthesia
other name: TIVA group
intervention type: Drug
intervention name: Remifentanil
description: Narcotics
arm group label: Inhalation anaesthesia
arm group label: Intravenous anaesthesia
other name: TIVA group and inhalation group
intervention type: Drug
intervention name: Dexmedetomidine
description: Total intravenous anaesthesia
arm group label: Intravenous anaesthesia
other name: TIVA group
intervention type: Drug
intervention name: Desflurane
description: Inhalation anaesthesia.
arm group label: Inhalation anaesthesia
other name: Inhalation group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Dr Ezzeldin Ibrahim
investigator title: Assistant Professor in anaesthesia, intensive care, and pain medicine.
mesh term: Dexmedetomidine
mesh term: Remifentanil
mesh term: Propofol
mesh term: Desflurane
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 