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Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

ConditionsOndansetronLozengeIntravenousPreventionShiveringCesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 40 years.

American Society of Anesthesiology (ASA) physical status II.

Parturient women undergoing cesarean section under spinal anesthesia.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group LExperimental treatment 1 intervention
Group B: Group OExperimental treatment 1 intervention
Group C: Group CNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
24 hours postoperatively

Secondary outcomes

1

Incidence of postoperative nausea and vomiting

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).

Time frame
24 hours postoperatively
2

Degree of patient 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).

Time frame
24 hours postoperatively
3

Incidence of adverse effects

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

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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