Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section

Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial

The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Ondansetron Lozenge; Post-Spinal Shivering
• Intervention / Treatment: Drug: Ondansetron lozenge

Detailed Description

Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.

Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.

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. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 18 to 40 years.
• American Society of Anesthesiology (ASA) physical status II.
• Parturient women undergoing CS 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.
• Temperature more than 38°C or less than 36°C.
• Body Mass Index (BMI)> 40 kg/m2.
• Medical history of alcohol or drug abuse.
• Parkinson's disease or any extrapyramidal disease.
• Intraoperative blood transfusion.
• History of chemotherapy treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S (Ondansetron lozenge); Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group.	Drug: Ondansetron lozenge; Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
No Intervention: Group C (Control); Patients will not receive ondansetron as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting (PONV)	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).	24 hours postoperatively
Patients' 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).	24 hours postoperatively
Adverse effects	Adverse events such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohammed S Elsharkawy, MD, Faculty of Medicine Tanta University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Actual): September 29, 2024
• Study Completion (Actual): September 29, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Ondansetron
• Other Study ID Numbers: 36264PR642/4/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No