Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy
• Intervention / Treatment: Drug: At-night Dexamethasone; Drug: At-induction Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Aldakahlia
    • Mansoura, Aldakahlia, Egypt, 35516
      • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea or vomiting (PONV)	incidence of PONV (binary outcome as yes/No)	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for rescue antiemetic	Dichotomous yes/no outcome	24 hours after surgery
The need for rescue analgesia	Dichotomous yes/no outcome	24 hours after surgery
Late PONV	Dichotomous yes/no outcome	6-24 hours after surgery
Visual Analogue Scale (VAS)	VAS as a scale 0 - 10	at the time of discharge from hospital (usually 24 hours after surgery)
Post-Discharge Nausea and Vomiting (PDNV)	evaluated by telephone by Dichotomous yes/no outcome	at 72 hours after surgery
Postoperative Care Unit (PACU) and Early PONV	Dichotomous yes/no outcome	within 6 hours after surgery
Visual Analogue Scale (VAS)	VAS as a scale 0 - 10	at the time of discharge from PACU (usually at 2 hours after surgery)
Postoperative quality of recovery (QoR)	QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)	24 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Itching or burning sensation	as described by the patient as dichotomous outcome yes/no outcome	during injection of the dexamethasone

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Moataz M Emara, MD, EDAIC, Mansoura University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

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: R.23.07.2239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The anonymised data will be available on appropriate response with the prinicipal investigator.
• IPD Sharing Time Frame: Within one year of study completion
• IPD Sharing Access Criteria: will be notified shortly
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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