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.: PACTR202108663604989 Date of Approval: 16/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing opioid free general anesthesia to traditional balanced general anesthesia regarding achievement of enhanced recovery in laparoscopic bariatric surgeries
Official scientific title Comparing opioid free general anesthesia to traditional balanced general anesthesia regarding achievement of enhanced recovery in laparoscopic bariatric surgeries
Brief summary describing the background and objectives of the trial Opioids have historically been a first-line therapy for surgical pain control. They were considered optimum and the mainstay for balanced anesthesia but recently the concerns about their side effects as respiratory depression, ileus, vomiting, tolerance; dependence and even immune depression were raised. The concept of opioid free anesthesia was introduced recently to provide a safer alternative that would provide benefits to selective group of patients as well as enhance recovery after surgery. The aim of the study is to measure the efficacy of opioid free general anesthesia in achieving Enhanced Recovery After Surgery (ERAS) in laparoscopic bariatric surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 08/08/2019
Actual trial start date 02/11/2019
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date 20/07/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Opioid free anesthesia Dexmedetomidine loading dose 1 microgram/kg total body weight Ketamine loading dose 0.5 mg/kg ideal body weight Dexmedetomidine maintenance dose 0.5microgram/kg/hr total body weight (infusion) Ketamine maintenance dose 0.25 mg/kg/hr ideal body weight( infusion) Infusion started before skin incision and stopped after skin closure • Ketamine and dexmedetomidine will be prepared in the same syringe (10 ml for induction and 50 ml for infusion) with doses:  Ketamine: 0.5 mg/kg (IBW), dexmedetomidine 1 g/kg (Total Body weight, TBW) for induction to be given over 10 minutes  Ketamine 0.25 mg/kg/h (IBW) and dexmedetomidine 0.5 g/kg/h (TBW) as infusion during operation starting before skin incisio 30
Control Group Traditional balanced anesthesia Loading dose 2 microgram/kg ideal body weight Maintenance dose 1microgram/kg/hr ideal body weight (infusion) Maintenance infusion was started before skin incision and stopped after skin closure • Fentanyl 2 g/kg (IBW) as induction dose in 10 ml syringe to be given over 10 minutes, and 1 g/kg/h in 50 ml syringe as infusion during operation starting before skin incision. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Undergoing a scheduled laparoscopic bariatric surgery under general anesthesia. • Age group: 18-65 years old • BMI 40 – 59.9 Kg/m2 • Pregnant or breast-feeding women • The need to change laparoscopic surgery to an open one. • Allergy to any of the drugs used in the study • 1st or 2nd degree Heart block • Chronic treatment by beta-blockers • HR < 50 bpm, • Heart failure with LVEF < 40%, • Epilepsy or seizures • Alcohol or drug abuse • Psychiatric disease • History of chronic pain Adult: 19 Year-44 Year,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 21/07/2019 Research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome o Time between the end of analgesic used and extubation o Time between extubation and reaching Aldrete score of 9 (when applicable). Extunation time and yime to reach Aldrete score of 9
Secondary Outcome o Postoperative pain score for 48 hours using the Visual Analogue Scale (VAS),Nalbuphine consumption during the 48 hours following extubation the Visual Analogue Scale, 30 min after recovery, hourly for 2 h and every 6 h for 48 h
Secondary Outcome o Postoperative hypoxemia. • Postoperative hypoxemia is defined as peripheral oxygen saturation (SpO2) < 92% on room air with a need for oxygen supplementation; the duration of oxygen treatment will be recorded. Withen 24 h after extubation
Secondary Outcome • Number of episodes of PONV. During the 24 h following extubation
Secondary Outcome Number of events of bradycardia, hypotension and hypertension during surgery.  Bradycardia is defined as: HR≤50 bpm  Hypotension is defined as a decrease in systolic blood pressure >20% of basal  Hypertension is defined as an increase in systolic blood pressure >20% of basal During surgery maximum duration 7 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principal investigator 85, new settlement new cairo Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdallah soudi 85,1st settlement new cairo Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Abdallah Soudi Dr.soudi2014@med.asu.edu.eg +201111228925 85, 1st settlement new cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer department of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Rafaat Abdelazim Raafat_Abdelazim@med.asu.edu.eg +201223498967 8 Mostafa elnahas street, nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Mohamed Alhadidy Mohamed_alaaeldin@med.asu.edu.eg +201005092648 17 zakr Hussein street nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification Study Protocol Following publication Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information