Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

Drug and Dosage Adjustment in Preventing Postoperative Nausea and Vomiting in Adult Patients Undergoing Elective Surgery Under General Anesthesia

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04719741

Enrollment

1000

Registered

2021-01-22

Start date

2023-05-01

Completion date

2024-08-20

Last updated

2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

nausea, vomiting, postoperative, dose adjustment

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.

Interventions

OTHERParallel Assignment

Prospective, Triple blinded, randomized, controlled trial

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Jordan

Contacts

Primary ContactAbdulRhman MA Ibnouf, MBBS

ibnouf@hotmail.com+962786468830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026