Clinical trial NCT05998317: Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy
Official title: Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Nausea and Vomiting
Postoperative Pain
Laparoscopic Cholecystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial superiority parallel trial. This is a pilot trial and the sample size will be updated after the pilot study completion and the approval of the local Institutional Review Board (IRB).
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative nausea or vomiting (PONV)
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: The need for rescue antiemetic
timeFrame: 24 hours after surgery
measure: The need for rescue analgesia
timeFrame: 24 hours after surgery
measure: Postoperative Care Unit (PACU) and Early PONV
timeFrame: within 6 hours after surgery
measure: Late PONV
timeFrame: 6-24 hours after surgery
measure: Visual Analogue Scale (VAS)
timeFrame: at the time of discharge from PACU (usually at 2 hours after surgery)
measure: Visual Analogue Scale (VAS)
timeFrame: at the time of discharge from hospital (usually 24 hours after surgery)
measure: Postoperative quality of recovery (QoR)
timeFrame: 24 hours after surgery
measure: Post-Discharge Nausea and Vomiting (PDNV)
timeFrame: at 72 hours after surgery
Other outcomes:
measure: Surgical Site Infection
timeFrame: at follow-up (usually at 7 days after surgery)
measure: Itching or burning sensation
timeFrame: during injection of the dexamethasone
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine
state: Aldakahlia
Study officials:
affiliation: Mansoura University Faculty of Medicine
name: Moataz M Emara, MD, EDAIC
role: STUDY_CHAIR
References: