Comparison of intravenous magnesium sulphate and intravenous esmolol in attenuating hemodynamic stress response during tracheal extubation

ISRCTN ISRCTN59382278
DOI https://doi.org/10.1186/ISRCTN59382278
Submission date
26/09/2025
Registration date
07/10/2025
Last edited
07/10/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Tracheal extubation is an important and integral procedure of general anesthesia. Tracheal extubation can lead to irritation of the airways, which may cause coughing, resulting in increased systolic and diastolic blood pressures (SBP and DBP) and an increase in intrathoracic pressure, potentially interfering with cardiac preload. Hypertensive subjects may exhibit an exaggerated response to tracheal extubation compared to normotensives. In patients with coronary artery disease, these changes can lead to myocardial ischaemia, left ventricular dysfunction, cardiac dysrhythmias, cerebral haemorrhage and reduction in ejection fraction. Esmolol is a short-acting, highly cardioselective beta-adrenergic receptor antagonist rapidly metabolized by plasma esterase. The rapid onset of action of esmolol prevents an acute increase in heart rate and arterial pressure, which occur at extubation. Magnesium is a naturally occurring calcium channel antagonist and a non-competitive antagonist of N-methyl D-aspartate (NMDA) receptor. The role of magnesium in blunting the hemodynamic response to endotracheal intubation and extubation is evolving. It has been shown that magnesium inhibits catecholamine release from adrenal medulla and adrenergic nerve endings. This study aims to compare esmolol and magnesium sulphate in attenuating hemodynamic response to extubation.

Who can participate?
Adult patients with no to mild systemic disease, aged 20-55 years

What does the study involve?
This study will involve patients undergoing surgery under general anaesthesia and who have been extubated at the end of the procedure. Participants will be randomly assigned to Group A to receive IV esmolol infusion 0.5 mg/kg diluted in 100 ml of normal saline over 10 minutes beginning 5 minutes pre-extubation, and Group B, who receive IV MgSO4 – 40 mg/kg diluted in 100 ml of normal saline over 10 minutes starting 5 minutes pre-extubation. It is a prospective comparative study, meaning it will follow patients forward in time and compare outcomes between groups. The research will take place over two years, with full ethical approval and informed consent obtained from all participants.

What are the possible benefits and risks of participating?
Benefits and risks not provided at registration

Where is the study run from?
Department of Anaesthesiology and Critical Care, Era’s Lucknow Medical College and Hospital, Lucknow, India.

When is the study starting and how long is it expected to run for?
February 2021 to July 2022

Who is funding the study?
Era’s Lucknow Medical College and Hospital, Lucknow, India.

Who is the main contact?
Dr Asad Khalid, asadkhalid30@gmail.com

Contact information

Dr Asad Khalid
Public, Scientific, Principal Investigator

Sarfarazganj
Lucknow
226003
India

Phone +91 9452810007
Email asadkhalid@gmail.com

Study information

Study designInterventional double-blinded randomized parallel group
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeEfficacy
Participant information sheet Not available in web format, please use contact details to request participant information sheet
Scientific titleComparison of intravenous magnesium sulphate and intravenous esmolol in attenuating hemodynamic stress response during tracheal extubation in patients undergoing surgery
Study acronymCMET
Study objectivesWhich drug, between intravenous esmolol and intravenous magnesium sulphate, is better for attenuating hemodynamic response to tracheal extubation?
Ethics approval(s)

Approved 17/02/2021, Era's Lucknow Medical College and Hospital Institutional Ethics Committee (Sarfarazganj, Hardoi Road, Lucknow, 226003, India; +919452810007; info@erauniversity.in), ref: ELMC&H/Rcell/EC/2021/101

Health condition(s) or problem(s) studiedHaemodynamic stress response during tracheal extubation
InterventionAfter surgery, operated patients were randomly assigned to groups A and B, with 40 individuals in each group using a computer-generated randomized table. After randomisation, Group A received IV esmolol infusion 0.5 mg/kg diluted in 100 ml of normal saline over 10 minutes beginning 5 minutes pre-extubation, whereas Group B received IV MgSO4 – 40 mg/kg diluted in 100 ml of normal saline over 10 minutes starting 5 minutes pre-extubation. If the patient experienced an adverse effect, the infusion was halted, and the patient was treated accordingly. After restoring neuromuscular inhibition and suctioning, subjects were extubated. Study vitals (SBP, DBP, MAP, and HR) were recorded before extubation, at the time of extubation, 5 mins, 10 mins and 15 mins post extubation
Intervention typeDrug
Pharmaceutical study type(s)Fixed dose response in 2 different drug groups at different points of time in multiple parameters
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Esmolol, magnesium sulphate
Primary outcome measureSBP, DBP, MAP and HR measured using a blood pressure cuff at baseline, at the time of intervention, 5, 10, and 15 minutes post-intervention
Secondary outcome measuresSBP, DBP, MAP and HR measured before giving the drug using a blood pressure cuff, at the time of intervention, 5, 10 and 15 minutes post-intervention in both parallel study groups
Overall study start date17/02/2021
Completion date31/07/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit20 Years
Upper age limit55 Years
SexBoth
Target number of participants80
Total final enrolment80
Key inclusion criteria1. ASA Grade-I and Grade-II patients, age 20-55 years, weight 40-75 kg
2. Patients undergoing surgery under General Anaesthesia, who will be extubated at the end of surgery
Key exclusion criteria1. Patients with an allergy to study drugs
2. Patients with ASA grade 3 or more
3. Patients taking any adrenergic or psychotropic drugs
4. Patients with hepatic or renal disease
5. Patients with lung disease such as COPD
Date of first enrolment23/02/2021
Date of final enrolment23/02/2021

Locations

Countries of recruitment

  • India

Study participating centre

Era's Lucknow Medical College and Hospital
Sarfarazganj
Lucknow
226003
India

Sponsor information

Funders

Funder type

Hospital/treatment centre

Era’s Lucknow Medical College and Hospital

No information available

Results and Publications

Intention to publish date02/02/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request, Published as a supplement to the results publication
Publication and dissemination planPlanned publication in peer reviewed journal
IPD sharing planThe datasets generated and/or analysed during the current study will be published as a supplement to the results publication or made available upon request from Asad Khalid, asadkhalid30@gmail.com. The names and IPD numbers of the participants, along with their contact details, will not be shared as the consent form obtained from participants made it clear, and a verbal assurance was given that the personal details of the participants will not be made public under any circumstances.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 07/10/2025 No No

Additional files

48068_Protocol.pdf

Editorial Notes

07/10/2025: Study's existence confirmed by the Era's Lucknow Medical College and Hospital Institutional Ethics Committee, India.