Anti-shivering Effect of Ondansetron

Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section

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

Study Overview

• Status: Unknown
• Conditions: Shivering; Ondansetron
• Intervention / Treatment: Drug: Normal saline; Drug: Ondansetron 4 MG; Drug: Ondansetron 8mg

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: normal saline; patients received normal saline for prevention of shivering during spinal anesthesia	Drug: Normal saline; normal saline used for prevention of spinal shivering; Other Names: placebo
Active Comparator: ondansetron 4MG; patients received 4 mg of ondansetron for prevention of spinal shivering	Drug: Ondansetron 4 MG; ondansetron 4 MG used for prevention of spinal shivering; Other Names: low ondansetron
Active Comparator: ondansetron 8MG; patients received 8 mg of ondansetron for prevention of spinal shivering	Drug: Ondansetron 8mg; ondansetron 8 MG used for prevention of spinal shivering; Other Names: high ondansetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of shivering	Incidence of shivering among patients in both groups	for 24 hours after spinal anesthesia

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2018
• Primary Completion (Anticipated): August 15, 2018
• Study Completion (Anticipated): September 15, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: IRB00008718/3167

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No