| CTRI Number |
CTRI/2025/09/094421 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients undergoing surgery with general anaesthesia to compare two doses of dexmedetomidine and their effects on blood pressure, heart rate, breathing, oxygen levels, sleepiness and amount of anaesthesia required. |
|
Scientific Title of Study
|
A comparative study to evaluate effect of two doses of dexmedetomidine on hemodynamic changes, sedation score and requirement of propofol in patients undergoing surgery under general anaesthesia in a tertiary care hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHATT JAINEEL DEVANG |
| Designation |
POST GRADUATE RESIDENT, PHARMACOLOGY |
| Affiliation |
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Pharmacology.GCS Medical college, Hospital and Research centre Opposite DRM office, near, Chamunda Bridge, Naroda Road, Ahmedabad.
Ahmadabad
GUJARAT
380025
India |
| Phone |
9898381679 |
| Fax |
|
| Email |
bhattjaineel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIPUL CHAUDHARI |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT, PHARMACOLOGY |
| Affiliation |
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Pharmacology.GCS Medical college, Hospital and Research centre Opposite DRM office, near, Chamunda Bridge, Naroda Road, Ahmedabad.
Ahmadabad
GUJARAT
380025
India |
| Phone |
9825444336 |
| Fax |
|
| Email |
drvip79@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VIPUL CHAUDHARI |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT, PHARMACOLOGY |
| Affiliation |
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Pharmacology.GCS Medical college, Hospital and Research centre Opposite DRM office, near, Chamunda Bridge, Naroda Road, Ahmedabad.
Ahmadabad
GUJARAT
380025
India |
| Phone |
9825444336 |
| Fax |
|
| Email |
drvip79@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology.GCS Medical college, Hospital and Research centre Opposite DRM office, near, Chamunda Bridge, Naroda Road, Ahmedabad, Gujarat, India. 380025. |
|
|
Primary Sponsor
|
| Name |
BHATT JAINEEL DEVANG |
| Address |
Department of Pharmacology.GCS Medical college, Hospital and Research centre Opposite DRM office, near, Chamunda Bridge, Naroda Road, Ahmedabad, Gujarat, India 380025 |
| 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 |
| BHATT JAINEEL DEVANG |
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
GCS Medical college, Hospital and Research centre Opposite DRM office, near, Chamunda Bridge, Naroda Road, Ahmedabad.
Ahmadabad
GUJARAT |
9898381679
bhattjaineel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GUJARAT CANCER SOCIETY MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z518||Encounter for other specified aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
0.5 Microgram/Kg. Single dose. Intravenous as a preanesthetic agent. |
| Intervention |
Dexmedetomidine |
1.0 Microgram/Kg. Single dose. Intravenous as a preanesthetic agent. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgeries under general anaesthesia(GA).
2.ASA(American Society of Anaesthesiologists) classification grade I or II. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the effects of two doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) on hemodynamic changes in patients undergoing surgery.
2.To study and compare the sedation score with two different dose of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg).
3.To study requirement of propofol in patients according to Dexmedetomidine dose. |
1. Baseline
2. 10 minutes after Dexmedetomidine administration
3. Immediately after induction
4. Immediately after intubation
5. 1 minute after intubation
6. 5 minutes after intubation
7. 10 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To study side effects related to dexmedetomidine if any. |
1. Baseline
2. 10 minutes after Dexmedetomidine
administration.
3. Immediately after induction
4. Immediately after intubation
5. 1 minute after intubation
6. 5 minutes after intubation
7. 10 minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/09/2025 |
| 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="2"
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
|
Several clinical studies have investigated the hemodynamic effects of dexmedetomidine across different dosages. A study by Ueshima et al. demonstrated that a dose of 0.5 mcg per kg of dexmedetomidine resulted in significant attenuation of the stress response without a notable increase in side effects. On the other hand, doses around 1.0 mcg per kg have shown greater efficacy in reducing heart rate and blood pressure, but with an increased incidence of bradycardia and hypotension. The optimal dose for achieving a balance between effective hemodynamic control and minimal adverse effects remains a subject of ongoing research. Given these findings, the present randomized, double-blind, prospective study aims to evaluate and compare the hemodynamic effects of intravenous dexmedetomidine at doses of 0.5 mcg per kg versus 1.0 mcg per kg in patients undergoing major surgeries under general anaesthesia. The goal is to identify the most effective and safe dosage regimen to optimize perioperative hemodynamic stability. |