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.: PACTR201802003104179 Date of Approval: 16/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Magnesium sulfate versus fentanyl to control pressor and arousal response to intubation
Official scientific title Bispectral index guided attenuation of pressor and arousal response to endotracheal intubation using magnesium sulfate and fentanyl . A doubleblind, randomized, controlled trial.
Brief summary describing the background and objectives of the trial Airway manipulation as laryngoscopy and intubation cause a series of hemodynamic changes as tachycardia, hypertension,increased pulmonary artery pressure,even arrhythmia which may cause serious complications in susceptible patients as myocardial ischemia, dangerous increase in intracranial pressure,or rupture aneurysm.These reactions may be partly due to inadequate depth of anesthesia. The objective of this trial is to compare the attenuating effect of Magnesium sulfate and Fentanyl on the pressor and arousal response to orotracheal intubation with the aid of Bispectral index monitoring to detect changes in anesthetic depth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied hemodynamic and arousal response to airway manipulation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2018
Actual trial start date 01/12/2017
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
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 randomisation using a radomisation 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 Group M 40mg/kg over 10 min 40mg/kg magnesium sulphate diluted in 50ml 0.9%saline for iv infusion over 10 min immediately before induction of general anesthesia. 25
Experimental Group Group F 2mcg/kg fentanyl infusion over 10min 2mcg/kg Fentanyl diluted in 50ml 0.9%saline for iv infusion over 10 min immediately before induction of general anesthesia. 25
Control Group Group C 50ml 0.9% saline infusion over 10min 50ml 0.9% saline for iv infusion over 10 min immediately before induction of general anesthesia. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female, Age 20-60yrs, general anesthesia with orotracheal intubation .Patients with chronic hypertension,heart disease,heart block,arrhythmia. .Renal Failure, heart failure. .On Beta and/or calcium channel blockers or any drug treatment that would affect blood pressure or heart rate. .Suspected difficult intubation. .More than 1 trial at intubation. .Intubation time >20sec 20 Year(s) 60 Year(s) Female
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 15/11/2017 Minia university ethical committee
Ethics Committee Address
Street address City Postal code Country
Main Road - Shalaby Land Minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Systolic blood pressure at 2 min post intubation. Baseline, after infusion of study drug, after induction, after intubation 2, 4, 6, 8, 10 12, 15 min
Secondary Outcome Systolic, Diastolic, Mean blood pressure, Heart rate, BIS Baseline, after infusion of study drug, after induction, after intubation 2, 4, 6, 8, 10 12, 15 min.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University Hospital corniche El Nile st. minia 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded minia university minia 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia department, minia university minia university minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Khaled A Abdou minia university hospital, corniche el Nile minia 11432 Egypt
Ahmed I Mohamed minia university hospital, corniche el Nile minia 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sohair Megalla Sohair.Adeeb@mu.edu.eg +2 01200036447 anesthesia department, minia university
City Postal code Country Position/Affiliation
minia 61519 Egypt
Role Name Email Phone Street address
Public Enquiries Ahmed Mohamed ahmedelbadawy1991@gmail.com +2 01063919246 anesthesia department, minia university
City Postal code Country Position/Affiliation
minia 61519 Egypt
Role Name Email Phone Street address
Scientific Enquiries Khaled Abdou khaledah55@gmail.com +2 01150397419 anesthesia department, minia university
City Postal code Country Position/Affiliation
minia 61519 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information