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.: PACTR202401561160798 Date of Approval: 24/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title comparative study between opioid usage and opioid free anesthesia in laparoscopic bariatric surgeries
Official scientific title Comparative study between opioid usage and opioid free anesthesia in laparoscopic bariatric surgeries
Brief summary describing the background and objectives of the trial Bariatric surgeries is rapidly increasing worldwide, and the concept of fast track surgery using laparoscopy have made bariatric surgeries cost-effective and efficient way of treating morbidly obese patients. It has been recommended to encourage opioid free anesthesia using non opioid agents during bariatric surgery.Opioid free anaesthesia (OFA) is the avoidance of opioids for pain treatment peri-operatively as an attempt to avoid opioid induced respiratory complications without patient discomfort. It is also a method used to Enhance Recovery After Surgery (ERAS) . The aim of this study was to investigate the potential advantages of using opioid free anesthesia in laparoscopic bariatric surgeries .
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 Prevention
Anticipated trial start date 30/10/2020
Actual trial start date 25/01/2021
Anticipated date of last follow up 01/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Recruiting
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Opioid Free Anesthesia in Laparoscopic Bariatric Surgeries Induction was done by propofol 2 mg/kg, analgesic dose of ketamine 0.25 mg /kg, dexmedetomidine 0.5 - 1 ug/ kg IBW, lidocaine 1.5 mg /kg IBW and magnesium 40 mg /kg IBW. The calculated doses of ketamine, dexmedetomidine, magnesium, lidocaine were prepared in 20 ml normal saline syringe given slowly over 10 minutes. After induction, maintenance was done by isoflurane 1-1.5 vol % ,ketamine infusion of 0.25 to 0.5 mg/kg IBW/h, dexmedetomidine infusion of 0.5 to 1 ug/kg IBW/h, Mg sulphate infusion of 5-10 mg/kg IBW/h and lidocaine infusion of 1.5 to 3 mg/kg IBW/h Iv ketamine infusion was adjusted to keep the BIS between 40-60. Intraoperative monitoring of vital signs was recorded every 30 minutes till the end of the procedure. Dexmedetomidine infusion and inhalational anesthesia were increased on occurrence of any sign of awareness or pain as tachycardia or hypertension. 25
Control Group opioid group anesthesia in laparoscopic bariatric surgery Induction was done by propofol 2 mg/kg and analgesic dose of fentanyl 2-4mcg / kg, the calculated dose of fentanyl was prepared in 20 ml normal saline syringe given slowly over 10 minutes. After induction maintenance was done by by isoflurane 1-1.5 vol %, fentanyl infusion of 0.025‑0.25 mcg/Kg/min of ideal body weight. Intraoperative monitoring of vital signs was recorded every 30 minutes till the end of the procedure. 2-3 mg of morphine boluses were given on occurrence of any signs of pain as tachycardia or hypertension. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult Patients of either sex . ASA I and II with body mass index 40-50 kg/m2. Scheduled for Laparoscopic bariatric surgery. Patients with history of drug abuse or who were dependent on opioid drugs. Patients with chronic pain. Patients with severe cardiac disease ,cirrhotic liver or neurological disease, epileptic will be excluded from the study. Allergy to the study drugs. Patients > 50 kg/m2. Expected duration of surgery > 3 hours. Adult: 19 Year-44 Year 19 Year(s) 45 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 19/11/2018 Researsh Ethics Committee at the Faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia ,Next to Al -nour Mosque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain monitoring through visual analogue pain score ( VAS ) score .Total fentanyl consumption from patient control anesthesia postoperative . VAS score at PACU, 30 minutes, 1hr,2hrs,4 hrs then every 4 hours for 24 hours. Total narcotic consumption through PCA and extra boluses of narcotics other than PCA for 24 hours in each group.
Secondary Outcome Hemodynamics in the form of heart rate (HR), blood pressure . Low oxygen level (spo2 < 94%). Delayed recovery Postoperative nausea and vomiting Shivering and feeling cold when will be discharged from the intensive care unit Hospital stay postoperative Hemodynamics after induction then every 30 minutes intraoperative ,at PACU,then every 2 hrs for 24hrs .SPO2 at PACU then every 30 minutes for 2 hrs,
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
faculty of medicine Ain shams uniersity 38 Abbassia ,Next to Al-Nour university cairo 1181 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
Heba Nasr Said Nassar 7 Ibn Kotaiba street-Nasr city Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Heba Nasr hebanasrnassar@gmail.com 01015872447 7 ibn kotaiba street, Nasr city
City Postal code Country Position/Affiliation
cairo 11566 Egypt Assistant Lecturer department of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mohamed El Sayed Hennawy Anahenno@yahoo.com 01227461022 El Rehab city group 102
City Postal code Country Position/Affiliation
cairo 11841 Egypt Professor of anesthesa Faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Rania Maher Hussein drrania_maamon@med.asu.edu.eg 01000544520 Masr el gededa
City Postal code Country Position/Affiliation
cairo Egypt Assistant lecturer of anesthesia at 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 Statistical Analysis Plan 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