Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

NCT ID: NCT04719741

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-08-20

Brief Summary

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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

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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O-4PI

4 mg Ondansetron given Pre-Induction

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

O-8PI

8 mg Ondansetron given Pre-Induction

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

O-4PE

4 mg Ondansetron given Pre-Emergence

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

O-8PE

8 mg Ondansetron given Pre-Emergence

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

D-4PI

4 mg Dexamethasone given Pre-Induction

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

D-8PI

8 mg Dexamethasone given Pre-Induction

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

D-4PE

4 mg Dexamethasone given Pre-Emergence

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

D-8PE

8 mg Dexamethasone given Pre-Emergence

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

O-4PI+D-8PI

4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

O-4PI+D-8PE

4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

O-4PE+D-8PI

4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

O-4PE+D-8PE

4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

Placebo Group

2 ml Saline 0.9%

Parallel Assignment

Intervention Type OTHER

Prospective, Triple blinded, randomized, controlled trial

Interventions

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Parallel Assignment

Prospective, Triple blinded, randomized, controlled trial

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jordan Hospital

OTHER

Sponsor Role lead

Responsible Party

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AbdulRhman MA. M. Ibnouf

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AbdulRhman MA Ibnouf, MBBS

Role: STUDY_DIRECTOR

Anaesthesia Department, Jordan Hospital

Locations

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Jordan Hospital

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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AbdulRhman MA Ibnouf, MBBS

Role: CONTACT

+962786468830

Facility Contacts

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AbdulRhman MA Ibnouf, MBBS

Role: primary

+962786468830

Other Identifiers

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JHANES000001

Identifier Type: -

Identifier Source: org_study_id

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