Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303703098345 Date of Registration: 01/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of combining Cyclizine, Metoclopramide or Ondansetron with Dexamethasone in prevention of Postoperative Nausea and Vomiting after Laparoscopic Sleeve Gastrectomy; A randomized controlled trial
Official scientific title Efficacy of combining Cyclizine, Metoclopramide or Ondansetron with Dexamethasone in prevention of Postoperative Nausea and Vomiting after Laparoscopic Sleeve Gastrectomy; A randomized controlled trial
Brief summary describing the background and objectives of the trial Although the multimodal pharmacological approach to PONV have been demonstrated in previous studies, there is a significant lack of evidence in highlighting the single best approach. thereafter, we are presenting this study to identify effective pharmacological combination for PONV prophylaxis in laparoscopic sleeve gastrectomy surgeries by presenting different drug combinations which are having different mechanisms of actions (central and peripheral action). The Aim of Study: The aim of this study is to asses the efficacy of different multimodal antiemetic prophylaxis in prevention of PONV which are having different mechanisms of actions (central and peripheral action) in morbidly obese patients undergoing laparoscopic sleeve gastrectomy surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 09/11/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 14/06/2023
Actual Last follow-up date 28/06/2023
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 210
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group C 6 months Two hundred and ten patients, undergoing laparoscopic sleeve gastrectomy surgery will be randomly allocated into three equal groups each using computerized generated random tables. Patients will receive drug combinations Immediately after induction of anesthesia: Group C (n =70): will receive intravenous Dexamethasone 8 mg+ Cyclizine 50 mg. 70
Control Group Group M 6 months will receive intravenous Dexamethasone 8 mg+ Metoclopramide 10 mg. 70 Active-Treatment of Control Group
Control Group Group O 6 months Group O (n =70): will receive intravenous Dexamethasone 8 mg+ Ondansetron 8 mg 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
⮚ Age (18 – 65). ⮚ Both gender ⮚ Body mass index (BMI) 40 to 50 kg/m2 ⮚ American Society of Anesthesiologist (ASA) - physical status III. ⮚ Patients undergoing laparoscopic sleeve gastrectomy surgery under general anesthesia. ● Patient refusal. ● Patients with known sensitivity or contraindication to drugs used in the study: ⮚ Cyclizing (Closed angle glaucoma, Enlarged prostate and Urinary bladder complete or incomplete blockage). ⮚ Metoclopramide (History of extrapyramidal disorders, Epilepsy, Parkinson's disease, mental illness and Intestinal obstruction). ⮚ Ondansetron (Agitation , Intestinal obstruction and Severe electrolytes imbalance ) ● Patients on steroids ( Immunosuppressant’s and Cancer therapy ) ● Patients on antiemetics.( Motion sickness , Severe cases of gastroenteritis and Other infections ) ● Patients on chronic opioid therapy ( Patients with malignancy ). ● Severe respiratory or cardiac disorders ( Bronchial asthma , laryngeal oedema , stridor , Respiratory failure , Heart failure, Arrhythmias and Patients with a pacemaker) ● Advanced liver or kidney disease Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2022 Cairo university
Ethics Committee Address
Street address City Postal code Country
Kasr alainy Cairo 12556 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of PONV in the 1st postoperative 24 hours (who will receive the rescue antiemetic when the PONV grade reaches ≥ 2 or the 10_points likert score reaches ≥ 4) 0to 10
Secondary Outcome ● Nausea and vomiting score will be recorded during the time periods 0 to 1, 1 to 6, 6 to 12, 12 to 24 hours postoperatively. ● 10-point Likert scale will be recorded during the time periods 0 to 1, 1 to 6, 6 to 12, 12 to 24 hours postoperatively. ● Time to 1st call for rescue analgesic. ● Post operative Visual analogue scale (VAS): 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively. ● Total dose of intraoperative fentanyle. ● Total dose of postoperative morphine in 24 hours. ● Total dose and boluses of the escape antiemetic ● Incidence of occurrence of drug induced complications: ⮚ Metoclopramide: extrapyramidal symptoms, dyskinesia, dystonia, convulsion, hypertonia and tremor, cardiac arrhythmia. ⮚ Ondansetron: headache, fatigue, dry mouth, malaise, and constipation. ⮚ Cyclizine: impairment of motor function, confusion, dizziness, blurred vision, dry mouth and throat, palpitations, tachycardia, abdominal distress, constipation and headache. ● patient satisfaction: the patients completed a simple questionnaire (0, very satisfied; 1, satisfied; 2, not satisfied). ● The sedation scores (Observer’s Assessment of Alertness⁄ Sedation scale) (where 1 =awake ⁄ alert, 2=light sedation, 3=moderate sedation, 4=deep sedation and 5 = deep sleep) will be recorded during the time periods 0 to 1, 1 to 6, 6 to 12, 12 to 24 hours postoperatively. ● Mean arterial Blood pressure (MAP), heart rate: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively. 0 to 10
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr alainy Kasr alainy Cairo 12556 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Mohamed Ali Street 33 Al Omrania 12556 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr alainy Kasr alainy Cairo 12556 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Badry mahmoud_badry2000@yahoo.com +201001844291 Mohamed Ali Street 33
City Postal code Country Position/Affiliation
Al Omrania 12556 Egypt MD
Role Name Email Phone Street address
Public Enquiries Ismail Hammad Ismailhamad87@yahoo.com 00201008105353 Manial sheha
City Postal code Country Position/Affiliation
Giza 11612 Egypt MD
Role Name Email Phone Street address
Scientific Enquiries Fatma Barghout Fatmaali9999111@gmail.com +201116696106 Giza
City Postal code Country Position/Affiliation
Giza 12556 Egypt Msc
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes, each bearing only the case number on the outside. A research assistant will be responsible for opening the envelope and preparing the study drug in identical syringes with the same volume of dilution to achieve a double-blinded study design (All the drugs will be prepared in 10 ml syringe and will be diluted with 0.9% normal saline to make the total volume 10ml). The anesthesiologists involved in patient observation and data collection will be blinded to the study group, as will the patients All of the individual participant data collected during the trial, after deidentification Data from this study will be available from the PI upon reasonable request and after the approval of Cairo University Study Protocol Data will be coded and entered using the statistical package SPSS version 22. Categorical data will be expressed frequency and proportion and will be compared by Chi Square. Numerical data will be summarized using mean and standard deviation. Comparisons between groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by Krauskal Wallis test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed within 12 months The sample size was calculated using G-power software. A previous study [25] reported that the incidence of PONV in laparoscopic surgery was 45% Assuming that either drug will decrease the incidence by at least 25%, a power of 80% and an alpha error of 0.05 (to allow comparison of three groups), the minimum sample size required will be 183 patients. we will increase it to 210 in each group to compensate for drop-outs 15% (70 in each group).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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