MedPath

prophylactic administration of intravenous ondansetron after spinal anesthesia for prevention of fall in blood pressure and heart rate

Active, not recruiting
Conditions
patients having inguinal hernia posted for surgical repair under spinal anesthesia
Registration Number
CTRI/2017/07/009098
Lead Sponsor
Indira Gandhi Institute of Medical Sciences Patna
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
All
Target Recruitment
100
Inclusion Criteria
  • 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.
Exclusion Criteria
    1. Patient refusal.
    1. Patients on opioid therapy/analgesics 3) Organ dysfunction, cardiac arrhythmia or congenital heart disease, and mental retardation.
    1. Patients with history of drug allergy to study drugs 5) Patients with known contra-indications to spinal anesthesia.
    1. Patient with co-morbidities such as hypertension, diabetes etc.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of hypotension after spinal anesthesia in patients with prophylactic intravenous ondansetronBlood pressure will be monitored at every minute interval for first 20 minute and then at 5 minute interval intra-operatively
Secondary Outcome Measures
NameTimeMethod
Incidence of bradycardia in patients having inguinal hernia repair under spinal anesthesia with prophylactic ondansetronHeart rate at 1 minute interval for first 20 minutes , then at 5 minute interval intra-operatively

Trial Locations

Locations (1)

Indira Gandhi Institute of Medical Sciences

🇮🇳

Patna, BIHAR, India

Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, BIHAR, India
Dr Saurav Shekhar
Principal investigator
9308921568
sauravshekhar99@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.