To check for the effect if intravenous ondansetron in prevention of spinal induced fall in blood pressure and shivering

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/08/035388
• Lead Sponsor: sharda hospital

Brief Summary

Spinal anaesthesiais a simple, reliable, and most common anaesthetic technique practicedworldwide 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 ablockade of sympathetic fibers leading to a drop in systemic vascularresistance.5,6Spinal-induced bradycardia is multifactorial but is in partdue to the Bezold–Jarisch reflex. This reflex is mediated by serotoninreceptors within the wall of the ventricle in response to systemic hypotension.It is thought that the stimulation of these peripheral 5-hydroxytryptaminesubtype 3 (5-HT3) receptors results in increasedparasympathetic activity and decreased sympathetic activity, resulting inbradycardia, vasodilatation, and hypotension. Serotonin isan additive trigger for BJR in hypovolemic patients. Ondansetron being one of the 5-HT3 receptor antagonist beingwidely used as an antiemetic agent, has been safely used to blunt theBezold–Jarisch reflex, resulting in less bradycardia and hypotension in humansundergoing spinal anesthesia.3,7

Also, Shivering is a common, undesirable perioperative eventin patients under spinal anesthesia.8,9 Perioperative shiveringhas a multitude of deleterious effects. These include patients’ discomfort, anincrease in oxygen consumption up to 500%, and increased risk of myocardialischemia.10 Shivering also induces artifacts in intraoperativemonitoring especially with electrocardiogram (ECG), noninvasive blood pressuremonitoring, and pulse oximetry.11 The mechanism of spinal anesthesia-inducedshivering is poorly understood. One proposed mechanism is that during spinalanesthesia, there is a block in sympathetic flow which leads to peripheralvasodilatation and increased cutaneous blood flow below the level of block.12 Thereis, subsequently, a core-to-periphery heat redistribution with an increasedheat loss to the environment. With a drop in body core temperature, theanterior hypothalamic thermoregulatory thermostat is reset and shivering responseis triggered above the level of block with the aim of raising metabolic heatproduction and core body temperature.12

Even thoughspinal anaesthesia is a simple and safe procedure, rare complications such asunresponsive hypotension, bradycardia and shivering are real anaestheticchallenges. It is preferred to prevent hypotension rather than treating it.Hence, in the recent past, most of the studies are focusing on prophylacticmanagement of hypotension and shivering; ondansetron is such a drug gainingpopularity in the prevention of hypotension and shivering in patients whounderwent subarachnoid block.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-02-08
• Study Start: 2021-07-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.ASA grade 1 & 2 2.Age 18-60 years 3.Patients scheduled for surgeries under spinal anaesthesia.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of intravenous ondansetron in preventing spinal anaesthesia induced hypotension and shivering	30 minutes

Secondary Outcome Measures

Name	Time	Method
a)To check for bradycardia	b)To check for intraoperative nausea and vomiting.

Trial Locations

Locations (1)

sharda hospital, school of medical sciences and research; 🇮🇳 Nagar, UTTAR PRADESH, India

sharda hospital, school of medical sciences and research

🇮🇳Nagar, UTTAR PRADESH, India

Dr Shivika Nath

Principal investigator

9999096812

doc.shivi45@gmail.com