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Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexamethasone 4 mg IV-control
Dexamethasone 4 mg IV
Dexamethasone 8 mg IV
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes mellitus

Sites / Locations

  • DiskapiYBERHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

control

4 mg

8 mg

Arm Description

patients with BMI=18.5-24.9 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.

patients with BMI>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.

patients with BMI>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

postoperative pain: 11-point VRS
Pain intensity will be measured using a simple 11-point VRS running from 0 (no pain) to 10 (unbearable pain), at rest and on mobilisation (asking the patient to cough).
oral intake
patients will be asked first oral fluid intake time charge criteria.
blood glucose
Fingerprick capillary blood glucose concentrations will be measured
Length of Hospital Stay
the time will be recorded when patients are discharged home
wound infection
Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection

Full Information

First Posted
August 13, 2020
Last Updated
September 6, 2021
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04538820
Brief Title
Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients
Official Title
Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients. compare the effectiveness of dexamethasone given in 4 mg and 8 mg doses in obese patients with 4 mg doses of dexamethasone in normal weight patients. 4 mg iv dexamethasone will be administered to normal weight patients at induction of anesthesia. This group will be classified as the control group. In obese patients (BMI>30 kg/m2), one group will receive 4 mg dexamethasone and other group will receive 8 mg dexamethasone at induction. Patients will receive general anesthesia with volatile anesthetics and tramadol will be administered IV at the end of surgery. Postoperative nausea and vomiting, postoperative pain, blood glucose, wound infection, time to oral intake, hospital stay will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
patients with BMI=18.5-24.9 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
Arm Title
4 mg
Arm Type
Active Comparator
Arm Description
patients with BMI>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
Arm Title
8 mg
Arm Type
Active Comparator
Arm Description
patients with BMI>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4 mg IV-control
Intervention Description
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4 mg IV
Intervention Description
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 8 mg IV
Intervention Description
dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting (PONV)
Description
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.
Time Frame
PONV scores wİll be record during the first 24 hours
Secondary Outcome Measure Information:
Title
postoperative pain: 11-point VRS
Description
Pain intensity will be measured using a simple 11-point VRS running from 0 (no pain) to 10 (unbearable pain), at rest and on mobilisation (asking the patient to cough).
Time Frame
Pain will be assessed during the first 24 hours
Title
oral intake
Description
patients will be asked first oral fluid intake time charge criteria.
Time Frame
during the first 24 hours
Title
blood glucose
Description
Fingerprick capillary blood glucose concentrations will be measured
Time Frame
at 6 and 10 hours after administration of dexamethasone
Title
Length of Hospital Stay
Description
the time will be recorded when patients are discharged home
Time Frame
during the first 24 hours
Title
wound infection
Description
Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection
Time Frame
postoperative 30th day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahar SAKIZCI UYAR
Phone
5057000240
Email
drsakizciuyar@gmail.com
Facility Information:
Facility Name
DiskapiYBERH
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahar SAKIZCI UYAR
Email
drsakizciuyar@gmail.com

12. IPD Sharing Statement

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Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

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