Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

Jordan Hospital

Status: Enrolling

Conditions: Postoperative Nausea and Vomiting

Treatments: Other: Parallel Assignment

Study type: Observational

Funder types: Other

Identifiers

NCT04719741

JHANES000001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 13 patient groups

O-4PI

Description:

4 mg Ondansetron given Pre-Induction

Treatment:

Other: Parallel Assignment

O-8PI

Description:

8 mg Ondansetron given Pre-Induction

Treatment:

Other: Parallel Assignment

O-4PE

Description:

4 mg Ondansetron given Pre-Emergence

Treatment:

Other: Parallel Assignment

O-8PE

Description:

8 mg Ondansetron given Pre-Emergence

Treatment:

Other: Parallel Assignment

D-4PI

Description:

4 mg Dexamethasone given Pre-Induction

Treatment:

Other: Parallel Assignment

D-8PI

Description:

8 mg Dexamethasone given Pre-Induction

Treatment:

Other: Parallel Assignment

D-4PE

Description:

4 mg Dexamethasone given Pre-Emergence

Treatment:

Other: Parallel Assignment

D-8PE

Description:

8 mg Dexamethasone given Pre-Emergence

Treatment:

Other: Parallel Assignment

O-4PI+D-8PI

Description:

4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction

Treatment:

Other: Parallel Assignment

O-4PI+D-8PE

Description:

4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence

Treatment:

Other: Parallel Assignment

O-4PE+D-8PI

Description:

4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction

Treatment:

Other: Parallel Assignment

O-4PE+D-8PE

Description:

4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence

Treatment:

Other: Parallel Assignment

Placebo Group

Description:

2 ml Saline 0.9%

Treatment:

Other: Parallel Assignment