Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Dexamethasone 4 mg IV-control; Drug: Dexamethasone 4 mg IV; Drug: Dexamethasone 8 mg IV

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bahar SAKIZCI UYAR; Phone Number: 5057000240; Email: drsakizciuyar@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • DiskapiYBERH
    • Contact: Bahar SAKIZCI UYAR; Email: drsakizciuyar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 92/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No