| CTRI Number |
CTRI/2025/04/085710 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which works better to reduce heart stress during intubation in patient undergoing surgery: Dexmedetomidine or Magnesium? |
|
Scientific Title of Study
|
Comparison of intravenous magnesium sulphate versus dexmedetomidine in blunting of cardiovascular stress response following laryngoscopy and endotracheal intubation- A prospective randomised control 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 Kauvya K |
| Designation |
Post Graduate |
| Affiliation |
PSG Institute of Medical Science and Research |
| Address |
Department of Anaesthesiology, A block second floor, Room no-1, PSG Institute of Medical Sciences and Research, Off Avinashi Road, Peelamedu, Coimbatore
Off, Avinashi Rd, Peelamedu
Coimbatore - 641004
Coimbatore
TAMIL NADU
641004
India |
| Phone |
7708563399 |
| Fax |
|
| Email |
kkauvya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanth Kumar M S |
| Designation |
Professor |
| Affiliation |
PSG Institute of Medical Science and Research |
| Address |
Department of Anaesthesiology, A block second floor Room no-1, PSG Institute of Medical Sciences and Research, Off Avinashi Road, Peelamedu, Coimbatore
Off, Avinashi Rd, Peelamedu
Coimbatore - 641004
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9344807280 |
| Fax |
|
| Email |
drprasanth1979@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kauvya K |
| Designation |
Post Graduate |
| Affiliation |
PSG Institute of Medical Science and Research |
| Address |
Department of Anaesthesiology, A block second floor Room no-1, PSG Institute of Medical Sciences and Research, Off Avinashi Road, Peelamedu, Coimbatore
Off, Avinashi Rd, Peelamedu
Coimbatore - 641004
Coimbatore
TAMIL NADU
641004
India |
| Phone |
7708563399 |
| Fax |
|
| Email |
kkauvya@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Institute of Medical Sciences and Research, Off Avinashi Road, Peelamedu, Coimbatore- 641004 |
|
|
Primary Sponsor
|
| Name |
Dr Kauvya K |
| Address |
Room no-451, PSG Institute of Medical Sciences and Research, Off Avinashi Road, Peelamedu, Coimbatore,Tamil Nadu 641004 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Kauvya K |
PSG Institute of Medical Sciences and Research |
Department of Anaestheiology, A block second floor- Operation theatre, Off Avinashi road, Peelamedu Coimbatore - 641004
Coimbatore
TAMIL NADU |
07708563399
kkauvya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, PSG IMS&R |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine dose of 0.75mcg/kg given as infusion in 100ml normal saline intravenously over 10 minutes used for blunting of cardiovascular stress response during laryngoscopy and endotracheal intubation |
| Intervention |
Magnesium Sulphate |
Magnesium Sulphate dose of 30mg/kg given as infusion in 100ml normal saline intravenously over 10 minutes used for blunting of cardiovascular stress response during laryngoscopy and endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anaesthesiologist class 1 & 2 |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Anticipated difficult airway
3.Unanticipated difficult airway requiring laryngoscopy time of more than 15 seconds
4.Obesity
5.Sinus bradycardia and any ECG abnormalities
6.Neuromuscular disorders
7.Allergic to study drug
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the changes in hemodynamic parameters following laryngoscopy and endotracheal intubation after administration of magnesium sulphate and dexmedetomidine
Heart rate,systolic blood pressure, diastolic blood pressure, mean arterial pressure will be recorded at following time intervals
Baseline
5,10, and 15 minutes since the start of drug infusion
30 seconds before laryngoscopy and intubation
1,3,5,10 after intubation |
In surgeries under general anesthesia using endotracheal tube |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the level of sedation using modified ramsay sedation score at 5,10,15 minutes since the start of drug infusion
|
In surgeries under general anesthesia using endotracheal tube |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="0"
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
|
Background: Laryngoscopy and endotracheal intubation are associated with a significant hemodynamic stress response leading to transient tachycardia and hypertension which may be detrimental to patients particularly with cardiovascular disease. Various pharmacological agents have been used to attenuate this stress response. This study aims to compare the efficacy of intravenous dexmedetomidine and magnesium sulphate in attenuation of cardiovascular stress response following laryngoscopy and endotracheal intubation Methods: This prospective, randomized, double blinded study involving 100 patients aged 20-10 years of either gender classified as ASA 1 or 2, undergoing surgeries under general anaesthesia in PSG Institute of Medical Sciences and Research, Coimbatore. Participants are divided into 2 groups of 50 each based on computer generated randomization sequence. Group M - receive magnesium sulphate of dose 30mg/kg and Group D - receive dexmedetomidine of dose 0.75mcg/kg, administered before induction. Hemodynamic parameters including heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure are noted at baseline, 5,10 and 15 minutes since start of drug infusion, 30 seconds prior to laryngoscopy and at intervals 1,3,5 and 10 minutes post intubation Conclusion: This study seeks to determine whether dexmedetomidine or magnesium sulphate more effective in attenuating the cardiovascular stress response during laryngoscopy and intubation. This finding will help guide anaesthetic management strategies, particularly in patients at risk of hemodynamic instability |