CTRI Number |
CTRI/2021/08/035388 [Registered on: 04/08/2021] Trial Registered Prospectively |
Last Modified On: |
02/08/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia Preventive |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
To check for the effect if intravenous ondansetron in prevention of spinal induced fall in blood pressure and shivering |
Scientific Title of Study
|
Evaluating the effect of intravenous ondansetron in prevention of spinal anaesthesia induced hypotension and shivering |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shivika Nath |
Designation |
Assistant Professor |
Affiliation |
school of medical sciences and research |
Address |
Department of Anaesthesiology, school of medical sciences and research, plot no 32,34, knowledge park 3, greater noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9999096812 |
Fax |
|
Email |
doc.shivi45@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shivika Nath |
Designation |
Assistant Professor |
Affiliation |
school of medical sciences and research |
Address |
Department of Anaesthesiology, school of medical sciences and research, plot no 32,34, knowledge park 3, greater noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9999096812 |
Fax |
|
Email |
doc.shivi45@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nupur Aggarwal |
Designation |
Pg 1st year anaesthesia |
Affiliation |
school of medical sciences and research |
Address |
Department of Anaesthesiology, school of medical sciences and research, plot no 32,34, knowledge park 3, greater noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9654145106 |
Fax |
|
Email |
nupur.aggarwal@sharda.ac.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
sharda hospital |
Address |
plot no 32, 34, knowledge park 3, greater noida, uttar pradesh- 201310 |
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 Shivika Nath |
sharda hospital, school of medical sciences and research |
Department of Anaesthesiology, 2nd floor, b block Gautam Buddha Nagar UTTAR PRADESH |
9999096812
doc.shivi45@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics 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 |
Comparator Agent |
Intravenous normal saline |
0.9% Normal Saline: An isotonic concentration of sodium chloride |
Intervention |
Intravenous Ondansetron |
5-HT3 receptor antagonist being widely used as an antiemetic agent, has been safely used to blunt the Bezold–Jarisch reflex, resulting in less bradycardia and hypotension in humans undergoing spinal anesthesia. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. ASA grade 1 & 2
2. Age 18-60 years
3. Patients scheduled for surgeries under spinal anaesthesia
|
|
ExclusionCriteria |
Details |
1. Patients in whom spinal anesthesia is contraindicated(absolute and relative contraindications)
2. Patients having known allergy to ondansetron,
3. Patients having hypertension (HTN) and coronary artery disease
4. Patients who are taking selective serotonin reuptake inhibitors or treatment for migraine
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the effect of intravenous ondansetron in preventing spinal anaesthesia induced hypotension and shivering |
30 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
a) To check for bradycardia
b) To check for intraoperative nausea and vomiting.
|
2 hours |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
07/08/2021 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Spinal anaesthesia
is a simple, reliable, and most common anaesthetic technique practiced
worldwide for lower limb, lower abdominal surgeries.1,2However,
spinal anaesthesia is associated with side effects such as hypotension,
bradycardia, and shivering.3,4Hypotension after spinal anesthesia is initially due to a
blockade of sympathetic fibers leading to a drop in systemic vascular
resistance.5,6Spinal-induced bradycardia is multifactorial but is in part
due to the Bezold–Jarisch reflex. This reflex is mediated by serotonin
receptors within the wall of the ventricle in response to systemic hypotension.
It is thought that the stimulation of these peripheral 5-hydroxytryptamine
subtype 3 (5-HT3) receptors results in increased
parasympathetic activity and decreased sympathetic activity, resulting in
bradycardia, vasodilatation, and hypotension. Serotonin is
an additive trigger for BJR in hypovolemic patients. Ondansetron being one of the 5-HT3 receptor antagonist being
widely used as an antiemetic agent, has been safely used to blunt the
Bezold–Jarisch reflex, resulting in less bradycardia and hypotension in humans
undergoing spinal anesthesia.3,7
Also, Shivering is a common, undesirable perioperative event
in patients under spinal anesthesia.8,9 Perioperative shivering
has a multitude of deleterious effects. These include patients’ discomfort, an
increase in oxygen consumption up to 500%, and increased risk of myocardial
ischemia.10 Shivering also induces artifacts in intraoperative
monitoring especially with electrocardiogram (ECG), noninvasive blood pressure
monitoring, and pulse oximetry.11
The mechanism of spinal anesthesia-induced
shivering is poorly understood. One proposed mechanism is that during spinal
anesthesia, there is a block in sympathetic flow which leads to peripheral
vasodilatation and increased cutaneous blood flow below the level of block.12 There
is, subsequently, a core-to-periphery heat redistribution with an increased
heat loss to the environment. With a drop in body core temperature, the
anterior hypothalamic thermoregulatory thermostat is reset and shivering response
is triggered above the level of block with the aim of raising metabolic heat
production and core body temperature.12
Even though
spinal anaesthesia is a simple and safe procedure, rare complications such as
unresponsive hypotension, bradycardia and shivering are real anaesthetic
challenges. It is preferred to prevent hypotension rather than treating it.
Hence, in the recent past, most of the studies are focusing on prophylactic
management of hypotension and shivering; ondansetron is such a drug gaining
popularity in the prevention of hypotension and shivering in patients who
underwent subarachnoid block. |