Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288035
• Other study ID #: R.21.02.1191
• Status: Recruiting
• Phase: Phase 3
• Start date: March 4, 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: Moataz M Emara, MD, EDAIC
• Phone: +201064048848
• Email: mm.emara[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.

Description:

Background:

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration.

Methods:

This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial.

Discussion:

The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. Additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 814
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.

Exclusion Criteria:

• steroids or antiemetics within 1 week of surgery

• chronic opioid therapy

• history of allergy to any of the study drug

• serum creatinine > 1.4 mg/dl

• liver enzymes > triple the normal limits

• pregnancy

• patient refusal

• and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire

• laparoscopic surgery is converted to open surgery after enrollment

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone Oral
Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.
• Dexamethasone
Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection.

Locations

Country	Name	City	State
Egypt	Mansoura University Faculty of Medicine	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical Site Infection (at follow-up)	as evaluated by the surgeon	within 2 weeks - on the follow-up
Other	Itching or burning sensation on dexamethasone injections	Dichotomous yes/no outcome	during injection of the dexamethoasone
Primary	Postoperative nausea or vomiting (PONV)	incidecne of PONV	24 hours after surgery
Secondary	Rescue antiemetic	need for rescue antiemetic for 24 hours after surgery (Dichotomous yes/no outcome)	24 hours after surgery
Secondary	Early PONV	(Dichotomous yes/no outcome)	within 6 hours after surgery
Secondary	Late PONV	(Dichotomous yes/no outcome)	6 - 24 hours after surgery
Secondary	Visual Analogue Scale (VAS) at the time of discharge from PACU	On VAS scale as numerical outcome	within 2 hours at the time of discharge from PACU
Secondary	VAS at the time of discharge from hospital	On VAS scale as numerical outcome	after 24 hours at the time of discharge from the hospital
Secondary	Postoperative fatigue	on a 10-point scale	after 24 hours at the time of discharge from the hospital
Secondary	Postoperative quality of recovery	using the QoR-15 questionnaire	after 24 hours at the time of discharge from the hospital
Secondary	Post-Discharge Nausea and Vomiting (PDNV)	evaluated by telephone as a binary outcome	72 hours after surgery.