| CTRI Number |
CTRI/2025/04/084817 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of injection Dexmedetomidine on the vital signs and overall recovery of patient after surgeries under general anaesthesia. |
|
Scientific Title of Study
|
Effect of dexmedetomidine on hemodynamic and recovery responses during tracheal 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 |
Niveditha Kishore Srinivasan |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9082215575 |
| Fax |
|
| Email |
niveditha2899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of Anaesthesiology, 5th floor, Hi-Tech building, Dr D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of Anaesthesiology, 5th floor, Hi-Tech building, Dr D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, 5th floor, Hi-tech building, Dr. D.Y. Patil Medical College, Hospital and Research centre, Sant Tukaram Nagar, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Niveditha Kishore Srinivasan |
| Address |
Department of Anaesthesiology, 5th floor, Hi-Tech building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| 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 |
| Niveditha Kishore Srinivasan |
Dr. D.Y. Patil Medical College, Hospital and Research Centre |
Department of Anaesthesiology, 5th floor, Hi-Tech building, Dr D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
9082215575
niveditha2899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
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 |
| Intervention |
inj. Dexmedetomidine |
inj. Dexmedetomidine 0.5mcg/kg will be given intravenously in 100ml Normal Saline over 15 minutes prior to extubation |
| Comparator Agent |
Normal Saline |
100ml Normal Saline will be given intravenously over 15 minutes prior to extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients in age group of 18 to 65 years of either sex
2) American Society of Anaesthesiology(ASA) grade I and II
3) Hemodynamically stable patients with all routine investigations within the normal
limits.
4) Patients who give informed written consent and are willing to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1) Patients with bleeding disorders or on anticoagulants
2) History of allergy to the drug being used under study
3) Patients unable to comprehend VAS/ known neurological/psychiatric illness
4) ASA III or above
5) Patients with severe cardiovascular or respiratory disorders or difficult airway
6) Patients on medications that affect heart rate (HR) or blood pressure (BP), pregnant,
currently breastfeeding women, history of sleep apnea
7) Patients for emergency procedures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of dexmedetomidine on hemodynamic and recovery responses during tracheal extubation |
Hemodynamic parameters will be assesed just prior to administration of study drug.
After giving study drug at 5, 10 and 15 minutes
Post extubation at 3 and 5 minutes.
Post operatively at 0, 5, 10, 15, 20, 25 and 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Dexmedetomidine on hemodynamic and recovery responses during tracheal extubation |
Ramsay Sedation score and Extubation Quality score after extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/04/2025 |
| 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
|
This is a prospective, randomised, double-blinded comparative study to compare the effect of inj. Dexmedetomidine versus normal saline(placebo), both given intravenously over 15 minutes prior to extubation, on hemodynamic parameters and recovery responses during tracheal extubation. Hemodynamic parameters will be assessed just prior to and after administration of the study drug and then at regular intervals of 5 minutes till 30 minutes in the post operative period. Extubation parameters(cough responses) will be assessed according to the Extubation Quality Score and undue sedation will be assessed according to Ramsay Sedation Score in the post operative period after 30 minutes. Any drug related adverse effects will be assessed in the post operative period. |