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NCT Number: NCT07511491

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

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

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Key information

Conditions

Ondansetron Cesarean Section Intravenous Lozenge Prevention Shivering

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

Salma E Kandil, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ondansetron lozenge

Drug

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

Ondansetron intravenous

Drug

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

Primary outcomes

  1. Incidence of shivering

    Time frame: 24 hours postoperatively

    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

    • Piloerection or peripheral vasoconstriction but no visible shivering
    • Muscular activity in only one muscle group
    • Muscular activity in more than one muscle group but not generalized shivering
    • Shivering involving the whole body

Secondary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours postoperatively

    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).

  2. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    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).

  3. Incidence of adverse effects

    Time frame: 24 hours postoperatively

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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