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.: PACTR201801002944228 Date of Approval: 05/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intravenous versus intraperitoneal Magnesium Sulfate in laparoscopic sleeve gastrectomy
Official scientific title Effect of intravenous versus intraperitoneal Magnesium Sulfate on hemodynamic parameters and postoperative analgesia during laparoscopic sleeve gastrectomy . A Prospective Randomized Study
Brief summary describing the background and objectives of the trial laparoscopic surgery is associated with significant changes in hemodynamic parameters due to pneumoperitoneum.The aim of the present study is to evaluate the efficacy of intravenous versus intraperitoneal instillation of Magnesium sulfate on attenuation of hemodynamic changes during laparoscopic bariatric surgeries As well as postoperative pain assessment, analgesic requirement and side effects
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/01/2018
Actual trial start date 15/01/2018
Anticipated date of last follow up 02/06/2018
Actual Last follow-up date 10/05/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control once once intravenous normal saline with intraperitoneal instillation of normal saline 40 Active-Treatment of Control Group
Experimental Group intravenous magnesium sulphate once once intravenous magnesium sulphate with intraperitoneal instillation of normal saline 40
Experimental Group intraperitoneal magnesium sulphate once once intravenous normal saline with intraperitoneal instillation of magnesium sulphate 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients of both sexes, aged 18-60 , ASA physical status I ¿II scheduled for elective laparoscopic bariatric surgeries patient refusal, severe respiratory or cardiac disorders, hepatic or renal insufficiency, allergy to any of the study drugs, pregnancy or breast-feeding 18 Year(s) 60 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 17/12/2017 research ethics committee of faculty of Medicine- Tanta University
Ethics Committee Address
Street address City Postal code Country
El geish Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemodynamic parameters hemodynamic parameters are measured at 1- Before loading infusions as a base line. 2- 1min after induction . 3- Before pneumoperitoneum. 4- 5,15,30,60 minutes after pneumoperitoneum 5- Five minutes after release of CO2. 6-on arrival to pacu
Secondary Outcome pain scores and postoperative analgesia once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital El geish Tanta 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University El geish Tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University El geish Tanta 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Blough El Mourad El geish Tanta 31257 Egypt
Sherif Kamal Hafez Arafa El geish Tanta 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Mourad monamorad80@gmail.com 0403332033 El geish
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Lecturer of anesthesia and surgical ICU Faculty of medicine-Tanta University
Role Name Email Phone Street address
Public Enquiries Mona El Mourad monamorad80@gmail.com 0403332033 El geish
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Lecturer of anesthesia and surgical ICU Faculty of medicine-Tanta University
Role Name Email Phone Street address
Scientific Enquiries Sherif Arafa sherifarafa1020@gmail.com 0403332033 El geish
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Lecturer of anesthesia and surgical ICU Faculty of medicine-Aswan University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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