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.: PACTR202111620456298 Date of Approval: 17/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between Intravenous and Intraperitoneal Magnesium Sulphate for Pain Management in Laparoscopic mini gastric bypass
Official scientific title Comparative Study between Intravenous and Intraperitoneal Magnesium Sulphate for Pain Management in Laparoscopic mini gastric bypass
Brief summary describing the background and objectives of the trial Background: Obesity is a widespread and growing condition with a significant impact on all aspects of healthcare including perioperative care. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity . Laparoscopic bariatric surgeries are now more popular than older open ones. Although the intensity of postoperative pain is low after laparoscopic surgeries, patients still experience postoperative pain. Intraperitoneal administration of some drugs can be effective for pain relief after laparoscopic surgery. Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic and endocrinal reflexes provoked by noxious stimuli. As intraperitoneal instillation of MgSO4 might attenuate the hemodynamic stress response to pneumoperitoneum and improve the patient’s satisfaction by decreasing postoperative complications, this study aimed to compare the effect of early instillation of MgSO4 before any dissection on hemodynamic response and its analgesic effect versus intravenous administration of MgSO4 in patients undergoing laparoscopic mini gastric bypass. Ojectives: The aim of the study is to compare the efficacy of intravenous versus intraperitoneal administration of MgSO4 in pain management in laparoscopic mini gastric bypass 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 01/12/2020
Actual trial start date 05/12/2020
Anticipated date of last follow up 30/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intraperitoneal Magnesium sulfate 50 ml/kg with 30 ml Normal Saline before CO2 insufflation once Receive 250 ml of isotonic 0.9% Normal Saline intravenously over 30 minutes with the beginning of operation. Then receive Magnesium sulphate 50 mg/kg in 30 ml of isotonic 0.9% Normal Saline intra peritoneal before insufflation of CO2. 50
Control Group intravenous magnesium sulfate Receive Magnesium sulphate 50 mg/kg in 250 ml of isotonic 0.9% Normal Saline once Receive Magnesium sulphate 50 mg/kg in 250 ml of isotonic 0.9% Normal Saline intravenously over 30 minutes with the beginning of operation. Then recieve 30 ml of isotonic 0.9% Normal Saline intra peritoneal before insufflation of CO2. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: • Undergoing a scheduled laparoscopic bariatric surgery under general anaesthesia. • Age group: 18-65 years old. • BMI 35– 59.9 Kg/m2. • Both genders are eligible for study. Exclusion Criteria: • Pregnant or breast-feeding women. • ASA physical status class > 3. • The need to change laparoscopic surgery to an open one. • Allergy to MgSO4. • 1st or 2nd degree Heart block. • Chronic treatment by beta-blockers. • HR < 50 bpm, • Heart failure with LVEF < 40%. • Severe chronic disease. • 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 18/11/2020 Research Ethics Committee at Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
Abbasya, Cairo, Egypt Cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome o Nalbuphine consumption during the 48 hours following extubation. 1 st 48h
Secondary Outcome o Postoperative pain score for 48 hours using the Visual Analogue Scale (VAS), 30 min after recovery, after 2 h, after 6 h and after 48 h.
Secondary Outcome o Number of episodes of PONV 1 st 24h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospitals AL-Khalyfa Al-Mamoun st, Abbasya Cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moustafa Galal Mahrous EL Sesy Shubra AL-Khayma Qalyubia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Abbasia Cairo 11517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ain Shams University Abbasia Cairo 11517 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa El Sesy ms.132.184@gmail.com 01123645525 Shubra Al-Khayma
City Postal code Country Position/Affiliation
Qalyubia Egypt Assisstant Lecturer
Role Name Email Phone Street address
Public Enquiries Moustafa El Sesy ms.132.184@gmail.com 01123645525 Shubra Al-Khayma
City Postal code Country Position/Affiliation
Qalyubia Egypt Assisstant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Moustafa El Sesy ms.132.184@gmail.com 01123645525 Shubra AL-Khayma
City Postal code Country Position/Affiliation
Qalyubia Egypt Assisstant Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification Study Protocol Immediately following publication, No end date Anyone who wishes to access the data for any purpose Data are available indefinitely at https://asja.springeropen.com/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://asja.springeropen.com/ 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