Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Nausea and Vomiting, Postoperative Pain, Laparoscopic Cholecystectomy

Intervention / Treatment
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* Drug: At-night Dexamethasone
* Drug: At-induction Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: At-night dexamethasone<br>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<br>* 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.<br>|
| Active Comparator: At-induction dexamethasone<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 
| Postoperative Care Unit (PACU) and Early PONV | Dichotomous yes/no outcome | within 6 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 PACU (usually at 2 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) | 
| Postoperative quality of recovery (QoR) | QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b) | 24 hours after surgery | 
| Post-Discharge Nausea and Vomiting (PDNV) | evaluated by telephone by Dichotomous yes/no outcome | at 72 hours after surgery |