Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

Phase 4

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Dexamethasone 8 mg IV; Drug: Dexamethasone 4 mg IV-control; Drug: Dexamethasone 4 mg IV

• Registration Number: NCT04538820
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-04
• Study Start: 2021-03-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-08
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
8 mg	Dexamethasone 8 mg IV	patients with BMI\>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
control	Dexamethasone 4 mg IV-control	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.
4 mg	Dexamethasone 4 mg IV	patients with BMI\>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.

Primary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting (PONV)	PONV scores wİll be record during the first 24 hours	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

Name	Time	Method
Length of Hospital Stay	during the first 24 hours	the time will be recorded when patients are discharged home
postoperative pain: 11-point VRS	Pain will be assessed during the first 24 hours	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).
blood glucose	at 6 and 10 hours after administration of dexamethasone	Fingerprick capillary blood glucose concentrations will be measured
wound infection	postoperative 30th day	Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection
oral intake	during the first 24 hours	patients will be asked first oral fluid intake time charge criteria.

Trial Locations

Locations (1)

DiskapiYBERH; 🇹🇷 Ankara, Turkey