Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04538820
• Other study ID #: 92/07
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2021
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Bahar SAKIZCI UYAR
• Phone: 5057000240
• Email: drsakizciuyar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• Dexamethasone 4 mg IV
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
• Dexamethasone 8 mg IV
dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients

Locations

Country	Name	City	State
Turkey	DiskapiYBERH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative nausea and vomiting (PONV)	The primary outcome is the overall incidence of PONV during the ?rst 24 h, de?ned 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 de?ne severe PONV as nausea with a score of at least 4 on the VRS, or vomiting.	PONV scores wIll be record during the ?rst 24 hours
Secondary	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 ?rst 24 hours
Secondary	oral intake	patients will be asked first oral fluid intake time charge criteria.	during the ?rst 24 hours
Secondary	blood glucose	Fingerprick capillary blood glucose concentrations will be measured	at 6 and 10 hours after administration of dexamethasone
Secondary	Length of Hospital Stay	the time will be recorded when patients are discharged home	during the ?rst 24 hours
Secondary	wound infection	Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection	postoperative 30th day