Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering

NCT07088601 | Not Yet Recruiting Phase 4

• 1 other identifier: MS-442-2024
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate the efficacy of oral ondansetron film strips on the incidence of post-spinal shivering in patients undergoing surgeries using spinal anesthesia at Kasr Alainy hospitals, Cairo University. This prospective, double-blinded, randomized controlled study will be conducted on 50 patients aged from 18 to 65 years of both sexes with ASA I, II who are scheduled for elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries. Patients will be divided into two equal groups: Group (O) will receive oral ondansetron in the form of an oral soluble film 4 mg strip immediately before insertion of IV cannula and group (C) will receive a placebo in the form of an oral peppermint strip immediately before insertion of the IV cannula.

Conditions

Post-Spinal Shivering

Outcome Measures

Primary Outcomes (1)

• The incidence of shivering.

  It is defined by the highest shivering score ≥ 3 at any time starting from 15 min after lumber puncture until 180 min following it.

  starting from 15 minutes after lumber puncture until 180 minutes following it and postoperative.

Secondary Outcomes (7)

• The onset time of significant shivering

  started from 15 minutes after lumbar injection until 180 minutes following lumbar injection and postoperative

• Incidence of hypothermia

  started from 15 minutes after lumbar injection until 180 minutes after lumbar injection and postoperative.

• The shivering score

  will be assessed at 15 minutes intervals during the operation and in the recovery room started from 15 minutes after the lumbar puncture until 180 minutes after the lumbar puncture and postoperative.

• Incidence of patients given pethidine

  started from 15 minutes after the lumbar puncture until 180 minutes after the lumbar puncture and postoperativde.

• Correlation between the incidence of shivering score ≥ 3 and hypothermia.

  started 15 minutes after lumbar puncture until 180 minutes after lumbar puncture and postoperatively

Other Outcomes (6)

• Demographic data including age, sex, and weight

  started immediately preoperatively until 1 minute before lumbar puncture

• ASA physical status.

  started immediately preoperatively until 1 minute before lumbar puncture

• Heart rate

  will be recorded at the following intervals: baseline (immediately before induction of spinal block), one minute after lumbar puncture, every 10 minutes in the first 30 minutes, then at 60 and 90 minutes intraoperatively and 30 minutes postoperatively

Study Arms (2)

Group O

ACTIVE COMPARATOR

Patients will receive oral ondansetron in the form of an oral soluble film 4 mg strip.

Drug: Oral ondansetron strips

Group C

PLACEBO COMPARATOR

Patients will receive a placebo in the form of an oral peppermint strip

Other: Placebo (oral peppermint strip)

Interventions

Oral ondansetron strips DRUG

In the anesthesia preparation room and before the insertion of the peripheral IV cannula, patients in group O will receive oral ondansetron in the form of an oral soluble film 4 mg strip.

Group O

Placebo (oral peppermint strip) OTHER

In the anesthesia preparation room and before the insertion of the peripheral IV cannula, patients in group C will receive a placebo in the form of an oral peppermint strip.

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I, II.
• Patients underwent elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries.

You may not qualify if:

• Patient refusal.
• Morbid obese patients or those who were not candidates for spinal anesthesia.
• Pregnant females.
• Patients with comorbidities such as severe cardiopulmonary, severe hepatic or renal diseases, thyroid disorders, and convulsions.
• Uncooperative patients and patients with psychological disorders.
• Patients on regular ondansetron or other antiemetics.
• Patients taking selective serotonin reuptake inhibitors.
• Patients with allergy to 5-HT3 receptor antagonist drugs.
• Patients receiving saddle spinal block.
• In surgeries less than 1 h or longer than 3 hours duration.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: August 10, 2025
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: July 30, 2025

Record last verified: 2024-12