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.: PACTR202105734020705 Date of Approval: 31/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intravenous Magnesium Sulphate Versus in Wetting solution in Counteracting Epinephrine Cardiac Adverse Events: Prospective Randomized controlled Trial.
Official scientific title Intravenous Magnesium Sulphate Versus in Wetting solution in Counteracting Epinephrine Cardiac Adverse Events: Prospective Randomized controlled Trial.
Brief summary describing the background and objectives of the trial This study will be conducted to evaluate the efficacy of intravenous versus wetting solution MgSO4 in counteracting epinephrine induced cardiac adverse events (e.g. tachyarrhythmia, and hypertension) as primary outcome, and its effect on pain scores and total analgesic requirement as secondary outcome.
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: Surgery
Anticipated trial start date 02/12/2020
Actual trial start date 06/03/2021
Anticipated date of last follow up 02/12/2021
Actual Last follow-up date 06/03/2022
Anticipated target sample size (number of participants) 129
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
Crossover: all participants receive all interventions in different sequence 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
Control Group evaluate the efficacy of intravenous versus wetting solution MgSO4 injection of the wetting fluid will 1 ml 1/1000 epinephrine will be added to every 1000 ml of normal saline and will not have MgSO4 neither intravenously nor in the wetting solution 24 hr injection of the wetting fluid will 1 ml 1/1000 epinephrine will be added to every 1000 ml of normal saline and will not have MgSO4 neither intravenously nor in the wetting solution evaluating systemic effect of epinephrine 43 Placebo
Experimental Group Intravenous Magnesium Sulphate Versus in Wetting solution in Counteracting Epinephrine side effects intravenous administration of MgSO4 (40 mg/kg) over 1 minute at the same time of wetting solution injection. 24 hr intravenous administration of MgSO4 (40 mg/kg) over 1 minute at the same time of wetting solution injection. 43
Experimental Group Intravenous Magnesium Sulphate Versus in Wetting solution in Counteracting Epinephrine side effects administration 40mg/kg of MgSO4 will be added to the wetting solution and will be divided equally according to the number of saline bottles injected in the wetting solution. 24 hr administration 40mg/kg of MgSO4 will be added to the wetting solution and will be divided equally according to the number of saline bottles injected in the wetting solution. 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients of both genders aged between 20 and 60 years. Classified by American society of anesthesiologists (ASA) I or II BMI 21-35 Kg/m2 who is preparing for abdominal liposuction procedure will be enrolled in our study. Patients' refusal to participate liposuction for other body part body mass index ≥40 known renal or hepatic insufficiency, cardiac disorders known allergy to study drugs. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 06/03/2021 research ethics committee faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluate the efficacy of intravenous versus wetting solution MgSO4 in counteracting epinephrine induced cardiac adverse events (e.g. tachyarrhythmia, and hypertension) as primary outcome 1 hour
Secondary Outcome evaluate the efficacy of intravenous versus wetting solution MgSO4on pain scores and total analgesic requirement as secondary outcome. 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta faculty of medicine university hospitals el geish street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine Tanta University elgeish street tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator dina elmalla dr_dina90@yahoo.com +201005336059 elgeish street
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer of Anaethesia and Surgical intensive care and pain management
Role Name Email Phone Street address
Scientific Enquiries motaz abusabaa motazabusabaa@gmail.com +201000029988 elgeish street
City Postal code Country Position/Affiliation
tanta 31527 Egypt Lecturer of Anaethesia and surgical intensive care and pain management
Role Name Email Phone Street address
Public Enquiries rehab helal roro_helal85@yahoo.com +201092268262 elgeish street
City Postal code Country Position/Affiliation
tanta 31527 Egypt Lecturer of Anaethesia and surgical intensive care and pain management
Role Name Email Phone Street address
Scientific Enquiries safwat hegazy safwathegazy2020@gmail.com +201225651415 elgeish street
City Postal code Country Position/Affiliation
Kafrelsheikh 33516 Egypt Lecturer of plastic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after identification Study Protocol 2 years open
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