Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Other: Parallel Assignment

• Registration Number: NCT04719741
• Lead Sponsor: Jordan Hospital

Brief Summary

The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.

Detailed Description

Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.

Study Timeline

• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-17
• Study First Posted: 2021-01-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29
• Study Start: 2023-05-01
• Primary Completion: 2024-05-20
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• ASA grade I and II
• Aged 18-70 years
• Patients scheduled for elective surgery under general anesthesia

Exclusion Criteria

• All patients who received antiemetics or cortisone within 48 hr before surgery
• Pregnant, breast feeding ladies
• Any patient with BMI (Body Mass Index) > 34 kg/m²
• Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses were also excluded from the study protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
O-4PI+D-8PE	Parallel Assignment	4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence
Placebo Group	Parallel Assignment	2 ml Saline 0.9%
D-8PE	Parallel Assignment	8 mg Dexamethasone given Pre-Emergence
O-8PE	Parallel Assignment	8 mg Ondansetron given Pre-Emergence
D-4PE	Parallel Assignment	4 mg Dexamethasone given Pre-Emergence
O-4PI+D-8PI	Parallel Assignment	4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction
O-4PE	Parallel Assignment	4 mg Ondansetron given Pre-Emergence
O-8PI	Parallel Assignment	8 mg Ondansetron given Pre-Induction
O-4PE+D-8PE	Parallel Assignment	4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence
O-4PI	Parallel Assignment	4 mg Ondansetron given Pre-Induction
D-4PI	Parallel Assignment	4 mg Dexamethasone given Pre-Induction
D-8PI	Parallel Assignment	8 mg Dexamethasone given Pre-Induction
O-4PE+D-8PI	Parallel Assignment	4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction

Primary Outcome Measures

Name	Time	Method
Presence of postoperative nausea and/or vomiting	24 hours	Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs

Trial Locations

Locations (1)

Jordan Hospital; 🇯🇴 Amman, Jordan