| CTRI Number |
CTRI/2025/07/090472 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative analysis of two different Dexmedetomidine dosages in
attenuation of hemodynamic response during extubation |
|
Scientific Title of Study
|
A Comparative study of two different Dexmedetomidine dosages in
attenuation of hemodynamic response during extubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandresh singh martoliya |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
Nainital
UTTARANCHAL
263139
India |
| Phone |
9719804773 |
| Fax |
|
| Email |
martoliyachandresh2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajay kumar sinha |
| Designation |
HOD and professor |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
drajayksinha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Chandresh singh martoliya |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
UTTARANCHAL
263139
India |
| Phone |
9719804773 |
| Fax |
|
| Email |
martoliyachandresh2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,critical care,pain and palliative medicine,Government medical college,Haldwani,Uttarakhand,INDIA-263139 |
|
|
Primary Sponsor
|
| Name |
Dr Chandresh singh martoliya |
| Address |
Department of Anaesthesiology,critical care,pain and palliative medicine,Government medical college,Haldwani,Uttarakhand,INDIA-263139 |
| 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 |
| Chandresh singh martoliya |
Susheela tiwari hospital |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
Nainital
UTTARANCHAL |
9719804773
martoliyachandresh2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,GMC,HALDWANI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K65-K68||Diseases of peritoneum and retroperitoneum, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The study population is divided into 2 groups-
Group A- Dexmedetomidine 0.50µg/kg IV given once 10 minutes before extubation
|
The study population is divided into 2 groups-
Group B- Dexmedetomidine 0.75µg/kg IV given once 10 minutes before extubation
|
| Comparator Agent |
The study population is divided into 2 groups-
Group A- Dexmedetomidine 0.5µg/kg
|
The study population is divided into 2 groups-
Group A- Dexmedetomidine 0.75µg/kg
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients undergoing elective surgeries under general anesthesia.
2. Age of the patient between 18-60 years.
3. BMI of the patient between 18.5-29.9kg/m2
.
4. Patients belonging to ASA class I and II.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect of different doses of Dexmedetomidine on Blood Pressure, Heart
rate, oxygen saturation and depth of anaesthesia. |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study and compare the quality of Extubation response with two different doses of Dexmedetomidine
2. To compare the duration of post-operative analgesia and requirement of post-operative analgesics with
two different doses of Dexmedetomidine.
3. To observe any side effect of Dexmedetomidine |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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 4 |
|
Date of First Enrollment (India)
|
19/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/07/2025 |
| 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 Yet Recruiting |
| 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
|
The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics
Committee in patients satisfying all inclusion and exclusion Criteria planned for short surgeries under GA.Patient will be kept nil per orally before surgery. An IV line will be secured.
Patient will be connected to multi parameter monitor for recording heart rate (HR), systolic blood pressure (SBP),
diastolic blood pressure (DBP), mean arterial pressure (MAP), SPO2.The patient will be premedicated with IV glycopyrrolate 0.01 mg/kg, IV midazolam 0.05mg/Kg and IV
Ondansetron 0.08 mg/Kg. Induction with Inj propofol 1-2 mg/Kg followed by IV vecuronium 0.1 mg/Kg for
muscle relaxation and cuffed endotracheal tube will be inserted smoothly. Intra-operatively patient’s HR, SBP,
DBP, MAP and SPO2 will be monitored. Patients will be extubated by the anaesthesiologist when the following
criteria are fulfilled: sustained head lift for 5 seconds, sustained hand grip for 5 seconds, and adequate level of
consciousness. HR, SBP, DBP, MAP, and SPO2 readings baseline (just prior to test drug infusion), 1, 3, 5, 7 and
10 minute during infusion, following reversal administration, just before extubation, after-extubation 1, 3, 5, 7,
10, 15, 30 minute were recorded. |