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NCT04719741 Clinical Trial

Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04719741
Other study ID # JHANES000001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date August 20, 2024

Study information
Verified date March 2022
Source Jordan Hospital
Contact AbdulRhman MA Ibnouf, MBBS
Phone +962786468830
Email ibnouf@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date August 20, 2024
Est. primary completion date May 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Parallel Assignment
Prospective, Triple blinded, randomized, controlled trial

Locations
Country Name City State
Jordan Jordan Hospital Amman

Sponsors (1)
Lead Sponsor Collaborator
Jordan Hospital

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT02143531 - Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting Phase 4
Completed NCT00734929 - Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy Phase 4