Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05998317
• Other study ID #: R.23.07.2239
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 8, 2023
• Est. completion date: November 20, 2023

Study information

• Verified date: January 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.

Description:

Background: Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. The aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to 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 intravenous (iv) administration. Methods: This is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. Adults (≥18 years) with American Society of Anesthesiology (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 IV Dexamethasone at time of induction of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60 patients will be recruited as a pilot study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 20, 2023
• Est. primary completion date: November 15, 2023
• 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 at gastrointestinal surgery center.

Exclusion Criteria:

• patient refusal
• use of steroids or antiemetic agents within 1 week of surgery
• chronic opioid therapy
• history of allergy to any study medications
• serum creatinine > 1.4 mg/dl
• liver enzymes more than triple normal limits
• pregnancy
• psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire
• Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Egypt	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	infection as defined by the surgeon) at the trocar's or the drainage tube sites.	at follow-up (usually at 7 days after surgery)
Other	Itching or burning sensation	as described by the patient as dichotomous outcome yes/no outcome	during injection of the dexamethasone
Primary	postoperative nausea or vomiting (PONV)	incidence of PONV (binary outcome as yes/No)	24 hours after surgery
Secondary	The need for rescue antiemetic	Dichotomous yes/no outcome	24 hours after surgery
Secondary	The need for rescue analgesia	Dichotomous yes/no outcome	24 hours after surgery
Secondary	Postoperative Care Unit (PACU) and 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)	VAS as a scale 0 - 10	at the time of discharge from PACU (usually at 2 hours after surgery)
Secondary	Visual Analogue Scale (VAS)	VAS as a scale 0 - 10	at the time of discharge from hospital (usually 24 hours after surgery)
Secondary	Postoperative quality of recovery (QoR)	QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)	24 hours after surgery
Secondary	Post-Discharge Nausea and Vomiting (PDNV)	evaluated by telephone by Dichotomous yes/no outcome	at 72 hours after surgery