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Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT04719741
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
AbdulRhman MA. M. Ibnouf, Jordan Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Postoperative Nausea and Vomiting 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Drug and Dosage Adjustment in Preventing Postoperative Nausea and Vomiting in Adult Patients Undergoing Elective Surgery Under General Anesthesia
Estimated Study Start Date : January 20, 2021
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : May 20, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Presence of postoperative nausea and/or vomiting [ Time Frame: 24 hours ]
    Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing elective surgery under general anesthesia
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719741


Contacts
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Contact: AbdulRhman MA Ibnouf, MBBS +962786468830 ibnouf@hotmail.com

Locations
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Jordan
Jordan Hospital Recruiting
Amman, Jordan, 11152
Contact: AbdulRhman MA Ibnouf, MBBS    +962786468830    ibnouf@hotmail.com   
Sponsors and Collaborators
Jordan Hospital
Investigators
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Study Director: AbdulRhman MA Ibnouf, MBBS Anaesthesia Department, Jordan Hospital
More Information
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Responsible Party: AbdulRhman MA. M. Ibnouf, Dr., Jordan Hospital
ClinicalTrials.gov Identifier: NCT04719741    
Other Study ID Numbers: JHANES000001
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbdulRhman MA. M. Ibnouf, Jordan Hospital:
nausea
vomiting
postoperative
dose adjustment
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
 Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes