Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

NCT05998317 | Completed Phase 2 DMC

• 1 other identifier: R.23.07.2239
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting; Postoperative Pain; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• postoperative nausea or vomiting (PONV)

  incidence of PONV (binary outcome as yes/No)

  24 hours after surgery

Secondary Outcomes (8)

• The need for rescue antiemetic

  24 hours after surgery

• The need for rescue analgesia

  24 hours after surgery

• Postoperative Care Unit (PACU) and Early PONV

  within 6 hours after surgery

• Late PONV

  6-24 hours after surgery

• Visual Analogue Scale (VAS)

  at the time of discharge from PACU (usually at 2 hours after surgery)

Other Outcomes (2)

• Surgical Site Infection

  at follow-up (usually at 7 days after surgery)

• Itching or burning sensation

  during injection of the dexamethasone

Study Arms (2)

At-night dexamethasone

EXPERIMENTAL

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

At-induction dexamethasone

ACTIVE COMPARATOR

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

Interventions

At-night Dexamethasone DRUG

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-night dexamethasone

At-induction Dexamethasone DRUG

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.

At-induction dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery at gastrointestinal surgery center.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Study Officials

• Moataz M Emara, MD, EDAIC

  Mansoura University Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 18, 2023
• Study Start: October 8, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 20, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within one year of study completion
• Access Criteria: will be notified shortly

Locations

EG (1)