| CTRI Number |
CTRI/2025/07/090863 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparision between Tramadol and Ketamine in prevention of shivering in TURP |
|
Scientific Title of Study
|
To compare the efficacy of intravenous Tramadol and Ketamine for prevention of shivering in patients undergoing transurethral resection of prostate under spinal anaesthesia |
| 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 Anju Rani |
| Designation |
Associate Professor |
| Affiliation |
Pt, BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesia
Pt. BD Sharma PGIMS , medical road, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9540526120 |
| Fax |
|
| Email |
anjudahiya88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Rani |
| Designation |
Associate Professor |
| Affiliation |
Pt, BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesia
Pt. BD Sharma PGIMS , medical road, Rohtak PIN 124001
Rohtak
HARYANA
124001
India |
| Phone |
9540526120 |
| Fax |
|
| Email |
anjudahiya88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Rani |
| Designation |
Associate Professor |
| Affiliation |
Pt, BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesia
Pt. BD Sharma PGIMS , medical road, Rohtak PIN 124001
Rohtak
HARYANA
124001
India |
| Phone |
9540526120 |
| Fax |
|
| Email |
anjudahiya88@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMS ROHTAK Pt BD Sharma University Of Health Scienca |
| Address |
Department of Anaesthesia
Pt BD Sharma University of health sciences, Rohtak
PIN 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 kusum |
Pt. B.D. Sharma Post Graduate Institute of Medical Sciences Rohtak, |
Department of Anaesthesia
Pt. B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana
PIN 124001
Rohtak
HARYANA |
8295377334
kusumbhardwaj0401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| biomedcal research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine |
Ketamine (0.25mg/kg) in 10ml normal saline IV infusion over 5 minutes |
| Comparator Agent |
Normal Saline |
Normal saline 10ml intravenous infusion over 5 minutes |
| Intervention |
tramadol |
Tramadol (0.5mg/kg) in 10ml normal saline IV infusion over 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Patients belonging to the American Society of Anaesthesiologists- Physical Status I and II and aged between 40 and 75years undergoing elective TURP under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
patients refusing to give consent, hypersensitivity to study drugs, who develop shivering before administeration to study drugs, patients on vasodilators/ vasocontrictors |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Both Tramadol and Ketamine have been succesfully used for their prophylactic role in shivering after neuraxial anaesthesia |
we will assess the shivering if any, every 5 minutes intraoperatively and every 10 minutes post operatively for 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate adverse effects associated with use of study drugs , if any like nausea/vomiting, sedation, hypotension also bradycardia |
Adverse effects will be assessed intra operatively as well as 1 hour after the surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/07/2025 |
| 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="0"
Months="4"
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
|
After reviewing the literature, we found that both Tramadol and Ketamine have been successfully used for their prophylactic role in shivering after neuraxial anaesthesia. Also, various studies have shown contradictory results on effectiveness of prophylactic low doses of tramadol and ketamine. There is also a gap in showing better prophylactic agents concerning the effectiveness of prevention of post spinal anaesthesia shivering incidence, severity and occurrence of adverse effects. After thorough search of literature, we could not find any research work done comparing the efficacy of intravenous tramadol and intravenous ketamine in prevention of shivering in patients undergoing TURP under spinal anaesthesia. Hence we intend to conduct this study to compare the efficacy of intravenous Tramadol and Intravenous ketamine for prevention shivering in patients undergoing transuretheral resection of prostate under spinal anaesthesia. |