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.: PACTR202003463247180 Date of Approval: 02/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of intravenous infusion of Magnesium Sulphate versus Dexmedetomidine on spinal anesthesia in bilateral inguinal hernia surgeries: A randomized controlled study. in bilateral inguinal hernia surgeries
Official scientific title Analgesic and hemodynamic effect of intravenous infusion of Magnesium Sulphate versus Dexmedetomidine on spinal anesthesia in bilateral inguinal hernia surgeries: A randomized controlled study.
Brief summary describing the background and objectives of the trial This prospective randomized, double-blinded controlled study included 60 patients scheduled for bilateral elective inguinal hernia surgery under spinal anesthesia at Kasr El-Aini Hospital. Patients randomly allocated to one of three groups (n=20 each) to receive 50ml of 0.9% saline intravenous infusion of either dexmedetomidine 0.5μg/kg/hour (group D) or magnesium sulphate 15 mg/kg/h (group M) or normal saline (group S). The primary outcome was the analgesic duration and the secondary outcomes were onset and duration of sensory and motor blockade, Perioperative hemodynamics and the Total 24 hours postoperative morphine consumption.
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 01/08/2018
Actual trial start date 07/08/2018
Anticipated date of last follow up 19/07/2019
Actual Last follow-up date 25/07/2019
Anticipated target sample size (number of participants) 55
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group magnisum sulphate 15 mg/kg/h 2 hours patients received MgSo4 in 50ml of 0.9% saline infusion at a rate of 15 mg/kg/h. infusion started just before spinal anesthesia Spinal anesthesia was administered at L3-L4 inter vertebral space in sitting position using 25G Quincke's needle and after ensuring free flow of cerebrospinal fluid, 3 ml of hyperbaric bupivacaine 0.5% (15 mg) was administered . 20
Experimental Group dexmedetomidine 0.5μg/kg/hour 2 hours patients received dexmedetomidine in 50ml of 0.9% saline solution infusion at a rate of 0.5μg/kg/hour . drug infusion started just before spinal anesthesia Spinal anesthesia was administered at L3-L4 inter vertebral space in sitting position using 25G Quincke's needle and after ensuring free flow of cerebrospinal fluid, 3 ml of hyperbaric bupivacaine 0.5% (15 mg) was administered 20
Control Group saline 50 ml of 0.9% saline infusion 2 hours patients received 50 ml of 0.9% saline infusion Spinal anesthesia was administered at L3-L4 inter vertebral space in sitting position using 25G Quincke's needle and after ensuring free flow of cerebrospinal fluid, 3 ml of hyperbaric bupivacaine 0.5% (15 mg) was administered intrathecally in all groups. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged between 20 and 60 years patients with American Society of Anesthesiologists (ASA) class I or class II physical status undergoing uncomplicated bilateral inguinal hernia. patients who refused to participate in the study patients with impaired mental status patients with coagulopathy history of allergic reactions to local anesthetics patients with severe cardiac, respiratory, neuropsychiatric, hepatic or renal diseases patients with history of chronic use of sedatives, narcotics, alcohol or drug abuse. 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 31/03/2018 Research ethics committee Cairo University
Ethics Committee Address
Street address City Postal code Country
al manial Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the total analgesic duration every hour postoperative
Secondary Outcome onset of sensory and motor blockade every minute after spinal anesthesia
Secondary Outcome duration of sensory and motor blockade every hour after spinal anesthesia
Secondary Outcome Perioperative hemodynamics (heart rate, blood pressure, stroke volume and cardiac output) intraoperative and postoperative for 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kasr alainy al manial street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university Almanial street Cairo 1552 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor department of anesthesia faculty of medicine cairo university al manial cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
inas farouk al manial cairo Egypt
ahmed fetouh almanial cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries inas farouk inasfarouk@hotmail.com 00201001587333 al manial
City Postal code Country Position/Affiliation
cairo Egypt cairo university
Role Name Email Phone Street address
Principal Investigator Bassant Abdelhamid bassantmohamed197@yahoo.com 00201224254012 Almanial
City Postal code Country Position/Affiliation
cairo Egypt Cairo university
Role Name Email Phone Street address
Public Enquiries Ahmed Fetouh fetouh89mnf@gmail.com +201000910635 almanial
City Postal code Country Position/Affiliation
cairo Egypt cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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