| CTRI Number |
CTRI/2025/01/079096 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ondansetron vs palonosetron for prevention of post spinal shivering in lower limb surgeries |
|
Scientific Title of Study
|
Comparison of efficacy of ondansetron and palonosetron for prevention of post spinal shivering in 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 |
Varsha Gupta |
| Designation |
Anaesthesia Resident |
| Affiliation |
MM institute of Medical Sciences and Research,Mullana,Ambala |
| Address |
Department of Anaesthesia,MM institute of Medical Sciences and Research,Mullana,Ambala,Haryana
Ambala HARYANA 133207 India |
| Phone |
9797736782 |
| Fax |
|
| Email |
guptavarsha960@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sapna Bansal |
| Designation |
Head of Department |
| Affiliation |
MM institute of Medical Sciences and Research,Mullana,Ambala |
| Address |
Department of Anaesthesia,MM institute of Medical Sciences and Research,Mullana,Ambala,Haryana
Ambala HARYANA 133207 India |
| Phone |
8168381441 |
| Fax |
|
| Email |
drsapna10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sapna Bansal |
| Designation |
Head of Department |
| Affiliation |
MM institute of Medical Sciences and Research,Mullana,Ambala |
| Address |
Department of Anaesthesia,MM institute of Medical Sciences and Research,Mullana,Ambala,Haryana
Ambala HARYANA 133207 India |
| Phone |
8168381441 |
| Fax |
|
| Email |
drsapna10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,MM Institute of Medical Sciences and Research, Mullana, Ambala |
|
|
Primary Sponsor
|
| Name |
Dr Sapna Bansal, Head of Department, Department of Anaesthesiology |
| Address |
MM,Institute of Medical Science and Research, Mullana, Ambala |
| 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 Varsha Gupta |
MM Institute of Medical Science and Research Centre |
Department of Anaesthesiology,2nd floor,Old Building, MM Institute of Medical Science and Research Centre Ambala HARYANA |
9797736782
guptavarsha960@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,MMIMSR,Mullana,Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posted for elective lower limb surgeries under spinal anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of two different drugs on postspinal shivering |
Group 2: patients will receive palonosetron 0.075mg 30minutes before spinal anaesthesia |
| Intervention |
Intravenous 5HT3 agents in Spinal Anarsthesia surgery |
Group1: patients will receive ondansetron 8mg 30 minutes before spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Age between 18-60years.
American Society of Anaesthesiologist (ASA) physical status1-2.
Patient scheduled for elective lower limb surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient with failed spinal
Patient with allergy to 5HT3 receptor antagonist drugs
Patients with coagulopathy PT/INR less than 1.5 or platelet count more than 1 lac per microlitre
Patient who need a blood transfusion
Prolonged surgical time led to the conversion of spinal anaesthesia to general anaesthesia
Refusal of consent for spinal anaesthesia
Patient with Parkinson’s disease
Patient with dysautonomia
Patients having any dysrhythmias and prolong QTc in preoperative ECG
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of prophylactic ondansetron and palonosetron in reducing the incidence and severity of post spinal shivering |
Intraoperative period after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study hemodynamic changes and adverse effects, if any.
|
Intraoperative period after spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="33" Sample Size from India="33"
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)
|
31/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/01/2025 |
| 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 defined as an involuntary , spontaneous oscillatory mechanical activity of skeletal muscle.It is a fasciculation of the face, jaw , head and muscle hyperactivity lasting longer than 15 seconds. It is a frequent complication following anaesthesia with an incidence of between 40 to 60% and 56.7% for general anaesthesia and neuraxial anaesthesia respectively. Shivering can cause due to multiple aetiology, it may be due to 1.physiological regulatory response to central hypothermia. 2. cytokine release due to surgical stress. 3. Uninhibited spinal reflexes, post-operative pain. 4. Hyper active sympathetic activities. It is worsened by vasodilatation from spinal anaesthesia that redistribute core body heat. Ondansetron is the first 5HT3 antagonist most widely used drug for prophylaxis of shivering due to its lower cost. It act both centrally and peripheral. It’s time of onset of action is 30 minutes and its elimination half life is 3 to 4 hours with pre-dominantly hepatic metabolism(2). It’s mechanism of action as an anti shivering is not clear but purposed to act centrally by inhibiting serotonin reuptake at the level of pre optic anterior hypothalamus.It’s most common minor adverse effects are headache and diarrhoea. Palonosetron is a second- generation 5HT3 receptor antagonist with a prolonged duration of action and higher receptor binding affinity than first generation agents (ondansetron). The mean terminal elimination half-life, following single iv dose, is approximately 40 hours. Palonosetron is eliminated from body through both renal excretion and metabolic pathways (CYP2D6). widely use to prevent postoperative and pregnancy induce nausea, vomiting. It is now being used as an post spinal shivering prevention and management as well. Its anti-shivering effect may be related to serotonin reuptake inhibition in pre-optic anterior hypothalamic region. Its common side effects are headache and constipation, rare effects include bradycardia and QTc prolongation <1% Since, chemically, ondansetron and palonosetron belong to the same class of drugs, both are expected to exert similar effects. However, most studies have reported ondansetron administration to be efficacious for prophylaxis of post spinal shivering, but studies on palonosetron have yielded conflicting results. Thus, this study will be carried out to compare the efficacy of ondansetron and palonosetron of post spinal shivering in lower limb surgeries.
|