Anti-shivering Effect of Ondansetron

Phase 2

• Conditions: Shivering; Ondansetron
• Interventions: Drug: Normal saline; Drug: Ondansetron 4 MG; Drug: Ondansetron 8mg

• Registration Number: NCT03530007
• Lead Sponsor: Assiut University

Brief Summary

Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

Detailed Description

Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection.

We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery.

The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-08
• Study Start: 2018-05-15
• Study First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21
• Primary Completion: 2018-08-15
• Study Completion: 2018-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age between 18-65 years
• Both sexes
• American Society of Anesthesiologists
• physical status I and II
• scheduled for lower limb surgery under spinal anesthesia

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Exclusion Criteria

• Uncooperative patients
• psychologically unstable patients
• obese patients with BMI >30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	Normal saline	patients received normal saline for prevention of shivering during spinal anesthesia
ondansetron 4MG	Ondansetron 4 MG	patients received 4 mg of ondansetron for prevention of spinal shivering
ondansetron 8MG	Ondansetron 8mg	patients received 8 mg of ondansetron for prevention of spinal shivering

Primary Outcome Measures

Name	Time	Method
incidence of shivering	for 24 hours after spinal anesthesia	Incidence of shivering among patients in both groups

Secondary Outcome Measures

Name	Time	Method
Axillary temperature	for 24 hours after spinal anesthesia	patient temperature measured from axillary site
incidence of nausea and vomiting	for 24 hours after spinal anesthesia	Incidence of nausea and vomiting among patients in both groups
core temperature	for 24 hours after spinal anesthesia	patient temperature measured from tympanic site
incidence of hypotension	for 24 hours after spinal anesthesia	Incidence of hypotension between patients in both groups