Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

  • STATUS
    Recruiting
  • End date
    Aug 20, 2024
  • participants needed
    1000
  • sponsor
    Jordan Hospital
Updated on 19 April 2022
anesthesia
nausea
ondansetron
dexamethasone

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.

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.

Details
Condition Postoperative Nausea and Vomiting
Treatment Parallel Assignment
Clinical Study IdentifierNCT04719741
SponsorJordan Hospital
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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
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