| CTRI Number |
CTRI/2025/11/097503 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing intravenous Clonidine and Intravenous Magnesium sulphate in decreasing hemodynamic response to laryngoscopy and intubation. |
|
Scientific Title of Study
|
A comparative study between intravenous Clonidine and intravenous Magnesium sulphate in attenuating hemodynamic response to laryngoscopy and intubation a randomised study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kruthi D |
| Designation |
Junior resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, navy layout, Hesargatta main road, Chikkabanavara, Banglore.
Bangalore
KARNATAKA
560090
India |
| Phone |
8317485658 |
| Fax |
|
| Email |
kruthidineshkumar1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreyavathi R |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiolgy, ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, 15 Hesarghatta road, Navy layout, ABG Layout, Chikkabanavara, Bengaluru.
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
shreyamurthy8993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreyavathi R |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiolgy, ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, Hesarghatta road, Navy layout, ABG Layout, Chikkabanavara, Bengaluru.
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
shreyamurthy8993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiolgy, ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, 15 Hesarghatta road, Navy layout, ABG Layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, navy layout, Hesargatta main road, Chikkabanavara, Banglore, Karnataka, India 560090.
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Kruthi D |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiolgy, ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, 15 Hesarghatta road, Navy layout, ABG Layout, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA |
8317485658
kruthidineshkumar1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Clonidine 1mcg/kg in 100 ml NS IV will be given to Group C over 10 mins and inj. Magnesium sulphate 30mg/kg in 100 ml NS over 10 mins will be given to group M. |
Intravenous drug will be given intaoperatively before intubation over 10 mins and hemodynamic response will be recorded before giving drug, immediately after giving
drug, just before induction, after induction followed by 1min, 3 min, 5min and 10 min after
intubation. |
| Comparator Agent |
Comparing Intravenous Clonidine and Intravenous Magnesium sulphate |
Out of 66 patients, 33 patients will receive Inj. Clonidine 1mcg/kg in 100 ml NS over 10 mins and 33 patients
will receive inj. Magnesium sulphate 30mg/kg in 100 ml NS over 10 mins before intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2.
Patients undergoing elective surgeries under GA.
Patients with BMI less than 30kg/m2
Patients consenting for study |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway
Pregnant and lactating women
Patient allergic to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the effectiveness of intravenous Clonidine versus intravenous Magnesium sulphate in attenuating the hemodynamic response to laryngoscopy and intubation in patients undergoing surgeries under general anaesthesia.
To determine which of the two drugs have less side effects |
Intraoperatively drug will be administered and hemodynamic responses will be recorded before giving drug, immediately after giving
drug, just before induction, after induction followed by 1min, 3 min, 5min and 10 min after intubation.
Any adverse effects during study will be noted intraoperatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomised study is designed to study the effectiveness of Intavenous Clonidine versus Intravenous Magnesium sulphate in attenuating the hemodynamic response to laryngoscopy and intubation and also to say which is better with less side effects in patients undergoing surgeries under general anaesthesia. This study will be carried out in 2 groups of patients who meet inclusion criteria. Patients are randomly allocated into 2 groups of 33 people each using the opaque sealed envelope method. Group C will receive Inj. Clonidine 1mcg/kg in 100 ml NS over 10 mins Group M will receive inj. Magnesium sulphate 30mg/kg in 100 ml NS over 10 mins. Intra-operatively monitors will be connected, baseline vitals will be noted like SBP, DBP, MAP, SPO2, HR. Rate pressure product will be calculated. At the end of infusion, induction of anaesthesia will be done with Inj. Propofol 2mg/kg. Followed by vecuronium 0.1mg/kg after recording hemodynamic measurements and ventilation with 100% oxygen. Intubation will be done with cuffed ETT of appropriate size after direct laryngoscopy. Hemodynamic response will be recorded before giving drug, immediately after giving drug, before induction, after induction followed by 1min, 3 min, 5min and 10 min after intubation. Any adverse effect during the study will be recorded. |