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.: PACTR201703002107862 Date of Approval: 17/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Magnesium Sulfate versus nalbuphine On Hemodynamic Responses To Orotracheal Intubation I
Official scientific title Efficacy of Magnesium Sulfate versus nalbuphine On Hemodynamic Responses To Orotracheal Intubation In Smokers
Brief summary describing the background and objectives of the trial The primary goal of this randomized study is to determine the efficacy of using intravenous magnesium sulfate versus nalbuphine on hemodynamic response to orotracheal intubation in smokers .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,smokers
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2017
Actual trial start date 02/04/2017
Anticipated date of last follow up 31/10/2017
Actual Last follow-up date 31/10/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 closed opaque envelope technique closed opaque envelope technique Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group M ( n = 40): will receive magnesium sulfate 50 mg/kg in a total volume 100 ml of normal saline Group M ( n = 40): will receive magnesium sulfate 50 mg/kg in a total volume 100 ml of normal saline over 15 minutes before induction of general anesthesia over 15 minutes before induction of general anesthesia Group M ( n = 40): will receive magnesium sulfate 50 mg/kg in a total volume 100 ml of normal saline over 15 minutes before induction of general anesthesia 40 Active-Treatment of Control Group
Experimental Group Group N ( n = 40 ): will receive nalbuphine 0.2mg/kg in a total volume 100 ml of normal saline over Group N ( n = 40 ): will receive nalbuphine 0.2mg/kg in a total volume 100 ml of normal saline over 15 minutes before induction of general anesthesia Group N ( n = 40 ): will receive nalbuphine 0.2mg/kg in a total volume 100 ml of normal saline over 15 minutes before induction of general anesthesia Group N ( n = 40 ): will receive nalbuphine 0.2mg/kg in a total volume 100 ml of normal saline over 15 minutes before induction of general anesthesia 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study population will include inpatients of the involved departments including neurosurgery, general, urology, ENT, plastic and orthopedic surgery, both sex, selected randomly according to American Society of Anesthesiologists(ASA) grade I , between the ages of 18-50 years. Exclusion criteria: - History or suspected difficult airway. - ASA physical status other than I. - Patients undergoing cardiac and neurosurgical procedures. - History of uncontrolled hypertension, myocardial ischemia, arrhythmias uncontrolled diabetes mellitus and cerebrovascular stroke. - Bronchial asthma. - Renal disease, liver dysfunction, pregnancy. - Patients on hypnotic or narcotic analgesic. - History of alcohol or drug abuse. - History of allergic reaction to opioids or any drug used in this study - Patients in whom the duration of laryngoscopy exceeded 30 seconds. 18 Year(s) 50 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
No 01/03/2017 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean arterial blood pressure a- Before the administration of the study drug. (baseline) b- After induction of anesthesia. (before intubation) c- At 1,5,10 minutes following tracheal intubation and before skin incision
Secondary Outcome heart rate a- Before the administration of the study drug. (baseline) b- After induction of anesthesia. (before intubation) c- At 1,5,10 minutes following tracheal intubation and before skin incision.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef university hospital BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor doaa rashwan ,Egypt giza 000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Samar Mohamed Ahmed Ahmed BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
doaa rashwan ,Egypt giza 000 Egypt
Reham Mohammed Mohammed Esawy BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samar Ahmed doaa_rashwan@hotmail.com 00201011270763 BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt 000 Egypt resident
Role Name Email Phone Street address
Public Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 ,Egypt
City Postal code Country Position/Affiliation
giza 000 Egypt assitant professor
Role Name Email Phone Street address
Scientific Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 ,Egypt
City Postal code Country Position/Affiliation
giza 000 Egypt assitant professor
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information