| CTRI Number |
CTRI/2024/02/062229 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of tramadol versus tapentadol
for prophylaxis of post spinal
shivering in patients undergoing lower
limb surgeries |
|
Scientific Title of Study
|
Efficacy of tramadol versus tapentadol
for prophylaxis of post spinal
shivering in patients undergoing lower
limb 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 |
Devangi Moudgil |
| Designation |
Resident Anaesthesia |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anaesthesia Himalayan Institute of Medical Sciences Joly Grant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8290911008 |
| Fax |
|
| Email |
devangimoudgil125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Kumar |
| Designation |
Professor |
| Affiliation |
HIMALAYAN INSTITUTE OF MEDICAL SCIENCE |
| Address |
Department of Anaesthesia Himalayan Institute of Medical Sciences Joly Grant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9458977411 |
| Fax |
|
| Email |
nidhikumar@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Kumar |
| Designation |
Professor |
| Affiliation |
HIMALAYAN INSTITUTE OF MEDICAL SCIENCE |
| Address |
Department of Anaesthesia Himalayan Institute of Medical Sciences Joly Grant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9458977411 |
| Fax |
|
| Email |
nidhikumar@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
| Himalayan Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Swami Rama Himalayan Institue |
| Address |
Himalayan Institute of Medical Science SRHU Joly Grant
248140, Dehradun, UK, India |
| Type of Sponsor |
Private 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 Devangi Moudgil |
Swami Rama Himalayan Institute |
Himalayan Institute of Medical Sciences Joly Grant
Dehradun
UTTARANCHAL |
8290911008
devangimoudgil125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swami Rama Himalayan University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1: Tab Tramadol |
Tab Tramadol 100mg will be given preoperatively 1 hour prior to surgery. Spinal anaesthesia will be given with 25g quinke needle 3ml ropivacaine heavy 0.75%.
Incidence of Shivering will be noted in post spinal period along with post operative nausea vomiting, sedation, pain assesment. |
| Intervention |
Group 2: Tab Tapentadol 50 mg
|
Tab Tapentadol 50 mg will be given preoperatively1 hour prior to surgery. Spinal anaesthesa will be given with 25G quinke needle 3ml ropivacaine heavy 0.75%. Incidence of shivering will be noted in post spinal period along with post operative nausea vomiting,sedation,pain assesment as compared to tramadol |
| Comparator Agent |
Group3: Placebo comparator agent |
Placebo starch tab will be given preoperatively1 hour prior to surgery. Spinal anaesthesa will be given with 25G quinke needle 3ml ropivacaine heavy 0.75%. Incidence of shivering will be noted in post spinal period along with post operative nausea vomiting,sedation,pain assesment as compared to tramadol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
ASA 1 and 2
Consent for spinal anaesthesia
surgery duration less than 2 hours |
|
| ExclusionCriteria |
| Details |
ASA 2 and 3
Refusal or contraindication for spinal
Significant cardiac disease, renal failure, asthama
Patient with chronic analgesic use
Patient with endocrine abnormalities like thyroid disease, diabetes and mental disorder
Current or recent ( within 14 days ) use of MAO inhibitors |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shivering characterstic and score |
till 6 hours after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ramsay sedation score |
6 hours post administration of drug |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 3 |
|
Date of First Enrollment (India)
|
07/02/2024 |
| 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
|
• Before administration of the oral premedication (study drug), each patients baseline heart rate, mean systemic arterial pressure, pulse oximetry, forehead temperature, tympanic membrane temperature and sedation score will be measured • One hour prior to surgery patients will receive following premedication drugs as per group randomisation with sips of water GROUP I : Tab. Tramadol 100 mg GROUP II: Tab. Tapentadol 50 mg GROUP III : Placebo • All the anaesthetic and surgical techniques were standardized. The operation theatres in which the operations will be performed are maintained at constant humidity (65%) and an ambient temperature of 20-22 degree Celsius. Thereafter case would be induced with 25 G spinal needle using ropivacaine heavy 0.75% 3 ml Primary objective would be to study incidence onset and grade of shivering Secondary outcome would be sedation,pain and post op nausea vomiting |