Clinical trial

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

Name

R.23.07.2239

Description

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.

Trial arms

Trial start

2023-10-08

Estimated PCD

2023-11-15

Trial end

2023-11-20

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

At-night dexamethasone

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.

Arms:

At-induction dexamethasone

Size

Primary endpoint

postoperative nausea or vomiting (PONV)

24 hours after surgery

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "The pharmacists will prepare the study drug, either dexamethasone or saline in 10 mL similar syringes, according to the allocation. The syringe will be labeled with the patient's name and the allocation group, A or B. The study participants, caregivers, data collectors, and data analysts will all be blinded. The pharmacists will not participate in the study.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-01-25

1 organization

2 products

3 indications

Organization

Mansoura University

Product

At-night Dexamethasone

Indication

Postoperative Nausea and Vomiting

Indication

Postoperative Pain

Indication

Gallbladder Removal

Product

At-induction Dexamethasone