| CTRI Number |
CTRI/2024/10/075777 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Tramadol, Ketamine, and Ondansentron in the prevention of post-spinal anaesthesia shivering. |
|
Scientific Title of Study
|
A comparative study of prophylactic Tramadol, Ketamine and Ondansetron in the prevention of intraoperative shivering in patients undergoing lower limb orthopaedic surgeries 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 |
M Thangadurai |
| Designation |
Postgraduate trainee |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Department of Anaesthesiology, Calcutta National Medical College and Hospital, Kolkata.
Kolkata WEST BENGAL 700014 India |
| Phone |
8124955359 |
| Fax |
|
| Email |
drthangaduraimbbs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sudeshna Bhar Kundu |
| Designation |
Associate professor |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Department of Anaesthesiology, Calcutta National Medical College and Hospital, Kolkata.
Kolkata WEST BENGAL 700014 India |
| Phone |
8777725424 |
| Fax |
|
| Email |
sudeshna04cmc@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Sudeshna Bhar Kundu |
| Designation |
Associate professor |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Department of Anaesthesiology, Calcutta National Medical College and Hospital, Kolkata.
Kolkata WEST BENGAL 700014 India |
| Phone |
8777725424 |
| Fax |
|
| Email |
sudeshna04cmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Calcutta National Medical College and Hospital, 32, Gorachand Road, Beniapukur, Kolkata, West Bengal, Pincode: 700014, India. |
|
|
Primary Sponsor
|
| Name |
M Thangadurai |
| Address |
Department of Anaesthesiology, Calcutta National Medical College and Hospital, 32, Gorachand Road, Beniapukur, Kolkata, West Bengal, Pincode: 700014, India. |
| 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 M Thangadurai |
Calcutta National Medical College and Hospital |
Neuro surgery – Orthopaedics operation theatre (NOOT), Third floor, Extended surgical block. Kolkata WEST BENGAL |
8124955359
drthangaduraimbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Calcutta National Medical College |
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 |
Ketamine |
Ketamine 0.2 mg/kg IV to be given 5 minutes before spinal anaesthesia. |
| Intervention |
Ondansetron |
Ondansetron 4mg IV to be given 5 minutes before spinal anaesthesia. |
| Intervention |
Tramadol |
Tramadol 0.5mg/kg IV to be given 5 minutes before spinal anaesthesia. |
| Comparator Agent |
Tramadol, Ketamine and Ondansetron |
Inter-comparison of Tramadol 0.5mg/kg IV, Ketamine 0.2 mg/kg IV, Ondansetron 4mg IV. All drugs are to be given 5 minutes before spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 18-45 years.
2. Either sex.
3. ASA physical status I & II undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients having contraindications for spinal anaesthesia like lack of consent, raised intracranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability.
2. Patients with known allergy to study drugs.
3. Patients with BMI > 30 kg/m2.
4. Patients ASA physical status III or more.
5. Patients having major cardiovascular, respiratory, renal, hepatic, metabolic, neurological or endocrine diseases.
6. Patients with failed spinal anaesthesia.
7. Patients requiring general anaesthesia.
8. Patients having history of convulsion.
9. An initial or core temperature more than 37.5 C or less than 35.5 C.
10. Patients receiving intraoperative blood transfusion.
11. Patients receiving any other anti-emetic.
12. Patients receiving tramadol, ketamine or ondansetron in the pre-operative period.
13. Patients having arrhythmia or prolonged QTc.
14. Patients with history of opiod/alcohol /substance abuse. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of shivering |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Severity of intraoperative shivering.
2. incidence of other side effects like nausea, vomiting, sedation. |
12 months. |
|
|
Target Sample Size
|
Total Sample Size="93" Sample Size from India="93"
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)
|
03/11/2024 |
| 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
|
Shivering is a normal
thermoregulatory mechanism in patients undergoing spinal anaesthesia. Spinal
anaesthesia impairs the thermoregulatory system by inhibiting vasoconstriction,
which plays an important role in temperature regulation. Spinal anaesthesia
also results in redistribution of core heat to the periphery from the trunk
below the level of block. Both these effects predispose patients undergoing
spinal anaesthesia to hypothermia and shivering. Studies in recent years have
shown that even mild hypothermia (10C – 20C) can triple the incidence of
adverse cardiac outcomes. Besides, other serious outcomes of post-spinal
shivering are an increase in surgical blood loss, increase in need for blood
transfusion, increase in oxygen consumption and carbon dioxide production by
two to three fold, increased catecholamine production, lactic acidosis,
increase in intraocular pressure, intracranial pressure etc. Shivering also
creates difficulty in monitoring the patients as most of the multi parameter
monitors used for anesthesia show erroneous values. Intravenous Tramadol has
been found to be effective in reducing the incidence of post spinal anesthesia
intraoperative shivering. Tramadol is a opioid class of drug, mu opioid agonist
with minimum effect at kappa and delta receptors. It also inhibits the reuptake
of serotonin and norepinephrine at the spinal cord level, which increases 5-OH
Tryptamine production. Above actions of Tramadol make it effective in
preventing and controlling post spinal anaesthesia shivering. Ketamine is also
effective in prevention of intraoperative shivering. Ketamine acts as NMDA
receptor antagonist and it decreases core to peripheral redistribution of heat
by direct central sympathetic stimulation and by blocking inhibition of
norepinephrine uptake into post ganglionic sympathetic nerve endings. Above
actions make Ketamine effective in prevention and controlling post spinal
anaesthesia shivering. Ondansetron has also been found to be effective in
prevention of intraoperative shivering. Ondansetron is 5-HT3 antagonist. It is
proposed to act centrally at the level of preoptic anterior hypothalamic region
by inhibition of serotonin reuptake in prevention of intraoperative shivering.
There is a lack of study in comparing the efficacy of Tramadol, Ketamine and Ondansetron
in preventing post spinal anesthesia shivering. Therefore, this study will be
conducted to compare the efficacy of Tramadol, Ketamine and Ondansetron in
preventing post-spinal intraoperative shivering. |