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.: PACTR202308591985746 Date of Registration: 17/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Magnesium sulphate versus dexmedetomidine for cough suppression during anesthetic emergence in smokers: A randomized double _ blind controlled trial
Official scientific title Magnesium sulphate versus dexmedetomidine for cough suppression during anesthetic emergence in smokers: A randomized double _ blind controlled trial
Brief summary describing the background and objectives of the trial Cough during the perioperative period is usually transient and self-limiting. On emergence from anesthesia, cough may protect against aspiration. However, cough can also result in perioperative morbidity, including tachyarrhythmia, arterial hypertension, cardiovascular collapse, and airway complications, and it may increase intracranial, intra abdominal, and intraocular pressure . Cigarette smokers known to have respiratory problems during induction of anesthesia with increased incidence of laryngospasm and cough during extubation as the integrity of epithelium lost by smoke irritation. Multiple medications have been shown to reduce emergence coughing, such as lidocaine (i.v., intracuff, topical, and tracheal routes), dexmedetomidine, fentanyl, and remifentanil. The aim of this study is to investigate and compare the effect of dexmedetomidine and magnesium sulphate on the prevention of emergence cough after general anesthesia in smokers performing lower abdominal surgeries.
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 Prevention
Anticipated trial start date 06/07/2022
Actual trial start date 20/07/2022
Anticipated date of last follow up 01/08/2023
Actual Last follow-up date 07/09/2023
Anticipated target sample size (number of participants) 165
Actual target sample size (number of participants) 165
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 magnesium sulphate 30 mg /kg over 10 minutes when surgeon started closure of subcutaneous tissue magnesium sulphate administrated 55
Experimental Group dexmedetomidine 0.5 mic /kg 10 minutes when surgeon started closure of subcutaneous tissue dexmedetomidine administrated 55
Control Group normal saline 100ml 10 minutes when surgeon started closure of subcutaneous tissue normal saline administrated 55 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA 1,ASA 2 cigarette smokers age 21_60 years old patients performing lower abdominal surgeries patients with history of pulmonary diseases patients under treatment with sedatives or beta blockers and angiotensin _ converting enzyme inhibitors any contraindication to use magnesium sulphate or dexmedetomidine Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 03/03/2022 research ethics committee
Ethics Committee Address
Street address City Postal code Country
abbasia cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome severity and incidence of cough from emergence from general anesthesia to PACU transfer
Secondary Outcome hemodynamic changes regarding blood pressure and heart rate , sedation degree for 30 minutes after drug infusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals abbasyia Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no faculty of medicine ain shams university cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine ain shams university abbasya near by elnor mosque cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed shahat m.shahat2018@gmail.com +201097510577 new cairo Al-Andalus compound
City Postal code Country Position/Affiliation
cairo 1181 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries sahar talaat saharta2000@hotmail.com +201001240236 new cairo
City Postal code Country Position/Affiliation
cairo 1181 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries mohamed ghoneim demerdash1975@gmail.com +201003969542 nasr city
City Postal code Country Position/Affiliation
cairo 1181 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual data collected during the trail after deidentification Study Protocol following publication any purpose
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