| CTRI Number |
CTRI/2025/11/097400 [Registered on: 13/11/2025] 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, Placebo Controlled Trial |
|
Public Title of Study
|
To assess effectiveness of study drug on vitals and pain relieving in lumbar spine surgeries. |
|
Scientific Title of Study
|
Efficacy Of Oral Clonidine On Intraoperative Hemodynamics And
Postoperative Analgesia In Patients Undergoing Lumbar Spine
Surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amruta Chaudhari |
| 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 |
| Phone |
8275691232 |
| Fax |
|
| Email |
camruta8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subha Vazhakalayil |
| Designation |
Professor ,Department of Anaesthesiology |
| 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 |
| Phone |
9558224077 |
| Fax |
|
| Email |
dr.subhajose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subha Vazhakalayil |
| Designation |
Professor, Department Of Anaesthesiology |
| 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 |
| Phone |
955822077 |
| Fax |
|
| Email |
dr.subhajose@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 ,Maharashtra , India Pincode-411018 |
|
|
Primary Sponsor
|
| Name |
Amruta Chaudhari |
| Address |
Department Of Anaesthesiology, 5th Floor, Hi-Tech Building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune. 411018 |
| 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 Amruta Chaudhari |
DR. D.Y. .Patil 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 |
8275691232
camruta8@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 |
T.Clonidine 100 mg , oral administration |
Oral T.Clonidine 100 mg should be given 45 minutes prior to surgery. |
| Comparator Agent |
T.Vutamin C 100 mg |
Oral T.Vitamin C 100 mg should be given 45 minutes prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA grade I or II fit patients.
2) Ages between 18 and 60 years.
3) Patients undergoing lumbar spine surgery.
4) Hemodynamically stable patients with all routine investigations within normal limits without any
other comorbidities.
5) Patients who are not on any cardiac related drugs.
6) Availability of written informed consent from concerned patients.
|
|
| ExclusionCriteria |
| Details |
1) Patients below the age of 18 and above the age of 60 year
2) ASA III and IV patients
3) Patients with liver dysfunction
4) Patients with the history of allergy to the study medication
5) Pregnancy
6) Patients undergoing scoliosis surgery or more than 5 level of
fusion
7) Patients with uncontrolled systemic disorders like diabetes mellitus, heart
disease, chronic hypertension, pulmonary disorders, etc.
8) Patients with spine deformities or local skin interactions overlying the lumbar
vertebral region
9) Patients with bleeding or coagulation disorders |
|
|
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 |
| Efficacy Of Oral Clonidine On Intraoperative Hemodynamics |
Postoperative Analgesia In Patients Undergoing Lumbar Spine Surgeries |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total doses of fentanyl used intraoperatively |
compare the incidence of adverse events |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/12/2025 |
| 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
|
It is a prospective, randomized, double blinded comparative study to compare the effects of oral clonidine on intraoperative hemodynamics and postoperative analgesia in placebo controlled study in patients undergoing lumbar spine surgery.
Parameters that will be compared between the two groups will be the pre-operative , after induction , after 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hour and postoperatively to see intraoperative hemodynamics and postoperative analgesia. |