Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04538820
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 21.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Dexamethasone 4 mg IV-control; Drug: Dexamethasone 4 mg IV; Drug: Dexamethasone 8 mg IV	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Dexamethasone 4 mg IV-control; dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients.
Active Comparator: 4 mg patients with BMI>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.	Drug: Dexamethasone 4 mg IV; dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
Active Comparator: 8 mg patients with BMI>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.	Drug: Dexamethasone 8 mg IV; dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. oral intake [during the first 24 hours]

   patients will be asked first oral fluid intake time charge criteria.

3. blood glucose [at 6 and 10 hours after administration of dexamethasone]

   Fingerprick capillary blood glucose concentrations will be measured

4. Length of Hospital Stay [during the first 24 hours]

   the time will be recorded when patients are discharged home

5. wound infection [postoperative 30th day]

   Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DiskapiYBERH	Ankara		Turkey

Sponsors and Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bahar SAKIZCI UYAR, medical doctor, Diskapi Yildirim Beyazit Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT04538820
• Other Study ID Numbers: 92/07
• First Posted: Sep 4, 2020
• Last Update Posted: Sep 8, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

No Results Posted as of Sep 8, 2021