CTRI Number |
CTRI/2017/07/009098 [Registered on: 21/07/2017] Trial Registered Prospectively |
Last Modified On: |
02/12/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
prophylactic administration of intravenous ondansetron after spinal anesthesia for prevention of fall in blood pressure and heart rate |
Scientific Title of Study
|
Prophylactic Intravenous ondansetron for prevention of hypotension during spinal anesthesia for inguinal hernia repair: a prospective randomized clinical study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Saurav Shekhar |
Designation |
Senior Resident |
Affiliation |
Indira Gandhi Institute of Medical Sciences |
Address |
Department of Anesthesia
Indira Gandhi Institute of Medical Sciences
Sheikhpura
Patna 800014
Patna BIHAR 800001 India |
Phone |
9308921568 |
Fax |
|
Email |
sauravshekhar99@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Saurav Shekhar |
Designation |
senior resident |
Affiliation |
Indira Gandhi Institute of Medical Sciences |
Address |
Department of Anesthesia
Indira Gandhi Institute of Medical Sciences
Patna 800014
Patna BIHAR 800014 India |
Phone |
9308921568 |
Fax |
|
Email |
sauravshekhar99@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Saurav Shekhar |
Designation |
Senior Resident |
Affiliation |
Indira Gandhi Institute of Medical Sciences |
Address |
Department of Anesthesia
Indira Gandhi Institute of Medical Sciences
Sheikhpura
Patna 800014
Patna BIHAR 800001 India |
Phone |
9308921568 |
Fax |
|
Email |
sauravshekhar99@gmail.com |
|
Source of Monetary or Material Support
|
Indira Gandhi Institute of Medical Sciences
Sheikhpura
Patna 800001
Bihar |
|
Primary Sponsor
|
Name |
Indira Gandhi Institute of Medical Sciences Patna |
Address |
Department of Anesthesia
Indira Gandhi Institute of Medical Sciences, Patna |
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 Saurav Shekhar |
Indira Gandhi Institute of Medical Sciences |
Department of Anesthesia
Indira Gandhi Institute of Medical Sciences
sheikhpura
Patna 800014 Patna BIHAR |
9308921568
sauravshekhar99@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Indira Gandhi Institute of Medical Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients having inguinal hernia posted for surgical repair under spinal anesthesia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Injection ondansetron |
Inj. ondansetron 8mg Intravenous single dose ( total volume made into 5ml) given 20 minutes prior to performing spinal anesthesia |
Comparator Agent |
normal saline |
normal saline 5ml intravenous 20 minutes prior to performing spinal anesthesia |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
patient aged between 20 - 50 yrs with weight 50-70 kgs
Patient posted for hernia repair surgery under spinal anesthesia
ASA physical status I & 2
Patients informed consent for participation in study
|
|
ExclusionCriteria |
Details |
1) Patient refusal.
2) Patients on opioid therapy/analgesics
3) Organ dysfunction, cardiac arrhythmia or congenital heart disease, and mental retardation.
4) Patients with history of drug allergy to study drugs
5) Patients with known contra-indications to spinal anesthesia.
6) Patient with co-morbidities such as hypertension, diabetes etc. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Incidence of hypotension after spinal anesthesia in patients with prophylactic intravenous ondansetron |
Blood pressure will be monitored at every minute interval for first 20 minute and then at 5 minute interval intra-operatively |
|
Secondary Outcome
|
Outcome |
TimePoints |
Incidence of bradycardia in patients having inguinal hernia repair under spinal anesthesia with prophylactic ondansetron |
Heart rate at 1 minute interval for first 20 minutes , then at 5 minute interval intra-operatively |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
31/07/2017 |
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="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Spinal Anesthesia is the most common type of anesthesia provided for various infra-umbilical surgeries. An undesired side effect often seen with the administration of a spinal anaesthetic is hypotension and bradycardia. Current treatments include fluids and vasopressors, with the latter known to have few side effects. The Bezold-Jarisch reflex is the likely cause of hypotension and bradycardia associated with spinal anesthesia1. This reflex is caused by stimulation of peripheral serotonin receptors 5-hydroxytryptamine (5-HT3 type). Ondansetron is a selective serotonin 5-HT3 receptor2 antagonist which may abolish the Bezold-Jarisch reflex response to spinal anesthesia. A knowledge gap exists, stimulating the current study to review on the use of ondansetron to prevent undesired cardiovascular effects of spinal anesthesia. Aim of the study is to study the effectiveness of intravenous ondansetron for prevention of hypotension and bradycardia during spinal anesthesia. Most of the studies conducted till now included caesarean section operation which itself has many factors to cause hypotension such as gravid uterus, blood loss etc. this is the reason we are chosing lower limb surgeris where the confounding factors causing hypotension are less. |