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NCT Number: NCT06423807

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

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

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Key information

Conditions

Ondansetron Lozenge Cesarean Section Post-Spinal 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

About this study

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.

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 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.

Treatment and study plan

Ondansetron lozenge

Drug

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

Secondary outcomes

  1. Incidence of postoperative nausea and vomiting (PONV)

    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. Patients' 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. Adverse effects

    Time frame: 24 hours postoperatively

    Adverse events such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 21, 2024
Registry last updated
Oct 8, 2024

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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