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.: PACTR202106844313299 Date of Registration: 07/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nebulized magnesium sulfate and stress response to endotracheal intubation
Official scientific title Preoperative nebulized magnesium sulfate, does it attenuate stress response during endotracheal intubation in controlled hypertensive patients: A prospective randomized controlled study.
Brief summary describing the background and objectives of the trial Manipulation of airway associated with variable hemodynamic stress response, which may be intolerable in patients with poor cardiac reserve. Many drug and techniques had been studied to attenuate such response. Magnesium sulfate decrease acetylcholine release, produce vasodilatation and bronchodilatation. Nebulized magnesium used in acute asthma attacks but not investigated to attenuate stress response.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MgSO4
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 25/05/2021
Actual trial start date
Anticipated date of last follow up 25/01/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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 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 Nebulized magnesium sulfate 500 mg over 10 min, 15 min before induction of anesthesia independent anesthesia technician will prepare nebulization fluids (5 ml), containing 500 mg magnesium sulfate, to be nebulized over 10 min 15 min before induction of anesthesia 50
Control Group nebulized saline 5 ml over 10 min, 15 min before induction of anesthesia independent anesthesia technician will prepare nebulization fluids (5 ml) saline as placebo. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults of both sex ASA I or II aging >40 years undergoing elective surgery with general anesthesia in mansoura university hospital • Patient refusal • Allergy to used drug • Altered liver or kidney function • Uncontrolled hypertension • Psychological problems. • Mallampati score >3 for difficult intubation. • History of difficult intubation in previous surgeries. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 80 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 19/04/2021 IRB mansoura university egypt
Ethics Committee Address
Street address City Postal code Country
elgomhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate pressure product Basal, after finishing nebulizer setting, after anesthesia induction before intubation, during intubation, 1,2,3,5,10 min after intubation
Secondary Outcome oxygen saturation Basal, after finishing nebulizer setting, after anesthesia induction before intubation, during intubation, 1,2,3,5,10 min after intubation
Secondary Outcome serum cortisol basal, 30 min after intubation
Secondary Outcome random blood sugar basal, 30 min after intubation
Secondary Outcome postoperative sore throat 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed adel aboelela khattab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university elgomhoria street elmansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
Role Name Email Phone Street address
Public Enquiries MOHAMED aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication, with Researchers who provide a methodologically sound proposal Proposal should be directed to m_abouelela@mans.edu.eg. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (irb_staff@mans.edu.eg)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
irb_staff@mans.edu.eg 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