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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: Parallel Assignment

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: AbdulRhman MA Ibnouf, MBBS; Phone Number: +962786468830; Email: ibnouf@hotmail.com

Study Locations

• Jordan
  • Amman, Jordan, 11152
    • Recruiting
    • Jordan Hospital
    • Contact: AbdulRhman MA Ibnouf, MBBS; Phone Number: +962786468830; Email: ibnouf@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective surgery under general anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
O-4PI; 4 mg Ondansetron given Pre-Induction	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
O-8PI; 8 mg Ondansetron given Pre-Induction	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
O-4PE; 4 mg Ondansetron given Pre-Emergence	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
O-8PE; 8 mg Ondansetron given Pre-Emergence	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
D-4PI; 4 mg Dexamethasone given Pre-Induction	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
D-8PI; 8 mg Dexamethasone given Pre-Induction	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
D-4PE; 4 mg Dexamethasone given Pre-Emergence	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
D-8PE; 8 mg Dexamethasone given Pre-Emergence	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
O-4PI+D-8PI; 4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
O-4PI+D-8PE; 4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
O-4PE+D-8PI; 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
O-4PE+D-8PE; 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial
Placebo Group; 2 ml Saline 0.9%	Other: Parallel Assignment; Prospective, Triple blinded, randomized, controlled trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jordan Hospital
• Investigators: Study Director: AbdulRhman MA Ibnouf, MBBS, Anaesthesia Department, Jordan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 20, 2024
• Study Completion (Anticipated): August 20, 2024

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 17, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: nausea; vomiting; postoperative; dose adjustment
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: JHANES000001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No