Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients
1 other identifier
interventional
150
1 country
1
Brief Summary
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2021
Shorter than P25 for phase_4
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
August 13, 2020
CompletedFirst Posted
Study publicly available on registry
September 4, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedSeptember 8, 2021
September 1, 2021
7 months
August 13, 2020
September 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative nausea and vomiting (PONV)
The primary outcome is the overall incidence of PONV during the first 24 h, defined as any episode of vomiting or nausea.Nausea will be measured using an 11-point verbal rating scale (VRS) running from 0 (no nausea) to 10 (the worst nausea imaginable). We will define severe PONV as nausea with a score of at least 4 on the VRS, or vomiting.
PONV scores wİll be record during the first 24 hours
Secondary Outcomes (5)
postoperative pain: 11-point VRS
Pain will be assessed during the first 24 hours
oral intake
during the first 24 hours
blood glucose
at 6 and 10 hours after administration of dexamethasone
Length of Hospital Stay
during the first 24 hours
wound infection
postoperative 30th day
Study Arms (3)
control
ACTIVE COMPARATORpatients with BMI=18.5-24.9 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
4 mg
ACTIVE COMPARATORpatients with BMI\>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
8 mg
ACTIVE COMPARATORpatients with BMI\>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
Interventions
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients.
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
Eligibility Criteria
You may qualify if:
- High risk patients for postoperative nausea and vomiting:
- Female
- No smoking
- BMI =18.5-24.9 for control group
- BMI \>30 for other groups
- undergo laparoscopic cholecystectomy
You may not qualify if:
- Diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DiskapiYBERH
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
August 13, 2020
First Posted
September 4, 2020
Study Start
March 1, 2021
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
September 8, 2021
Record last verified: 2021-09