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
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2024
CompletedMarch 29, 2022
March 1, 2022
1.1 years
January 17, 2021
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of postoperative nausea and/or vomiting
Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs
24 hours
Study Arms (13)
O-4PI
4 mg Ondansetron given Pre-Induction
O-8PI
8 mg Ondansetron given Pre-Induction
O-4PE
4 mg Ondansetron given Pre-Emergence
O-8PE
8 mg Ondansetron given Pre-Emergence
D-4PI
4 mg Dexamethasone given Pre-Induction
D-8PI
8 mg Dexamethasone given Pre-Induction
D-4PE
4 mg Dexamethasone given Pre-Emergence
D-8PE
8 mg Dexamethasone given Pre-Emergence
O-4PI+D-8PI
4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction
O-4PI+D-8PE
4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence
O-4PE+D-8PI
4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction
O-4PE+D-8PE
4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence
Placebo Group
2 ml Saline 0.9%
Interventions
Prospective, Triple blinded, randomized, controlled trial
Eligibility Criteria
Adult patients undergoing elective surgery under general anesthesia
You may qualify if:
- ASA grade I and II
- Aged 18-70 years
- Patients scheduled for elective surgery under general anesthesia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jordan Hospitallead
Study Sites (1)
Jordan Hospital
Amman, 11152, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbdulRhman MA Ibnouf, MBBS
Anaesthesia Department, Jordan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
January 17, 2021
First Posted
January 22, 2021
Study Start
May 1, 2023
Primary Completion
May 20, 2024
Study Completion
August 20, 2024
Last Updated
March 29, 2022
Record last verified: 2022-03