Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

Tanta University90 enrolled

Overview

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).

Spinal anesthesia has many advantages when used for cesarean section (CS). It is a popular technique with rapid onset and high success rate. Shivering is associated with increased metabolic activity and consumption of oxygen. In addition, arterial hypoxia, lactic acidosis, and interference with electrocardiogram monitoring could be associated with shivering. Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. This medicine also decreases nausea and vomiting intra-and post-operatively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ondansetron Lozenge Intravenous Prevention Shivering Cesarean Section

Interventions

Ondansetron lozengeDRUG

Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

Ondansetron intravenousDRUG

Patients will receive 8 mg of ondansetron IV just before the surgery.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age from 18 to 40 years. * American Society of Anesthesiology (ASA) physical status II. * Parturient women undergoing cesarean section under spinal anesthesia. Exclusion Criteria: * Parturient women with any contraindication or hypersensitivity to the study drugs. * Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial. * Preoperative shivering. * Preoperative fever (\>38°C). * Body mass index \> 40 kg/m2. * Medical history of alcohol or drug abuse. * Hypo- or hyperthyroidism. * Parkinson's disease or any extrapyramidal disease. * Intraoperative blood transfusion.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

RECRUITING

Outcomes

Primary Outcomes

Incidence of shivering

Shivering will be graded during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan and Tsai and Chu. 0 No shivering 1. Piloerection or peripheral vasoconstriction but no visible shivering 2. Muscular activity in only one muscle group 3. Muscular activity in more than one muscle group but not generalized shivering 4. Shivering involving the whole body

Time frame: 24 hours postoperatively

Secondary Outcomes

Incidence of postoperative nausea and vomiting

The incidence of nausea and vomiting will be evaluated through the Bellville scoring scale (lack of nausea and vomiting=0, nausea=1, nausea with belching=2, and vomiting=3).

Time frame: 24 hours postoperatively

Degree of patient satisfaction

Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

Time frame: 24 hours postoperatively

Incidence of adverse effects

Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.

Time frame: 24 hours postoperatively

Central Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870 mselsharkawy@med.tanta.edu.eg

Data from ClinicalTrials.gov

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