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Completed

NCT Number: NCT05998317

Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Medicine

Al Mansurah, Aldakahlia, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-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.

Primary outcomes

  1. postoperative nausea or vomiting (PONV)

    Time frame: 24 hours after surgery

    incidence of PONV (binary outcome as yes/No)

Secondary outcomes

  1. The need for rescue antiemetic

    Time frame: 24 hours after surgery

    Dichotomous yes/no outcome

  2. The need for rescue analgesia

    Time frame: 24 hours after surgery

    Dichotomous yes/no outcome

  3. Postoperative Care Unit (PACU) and Early PONV

    Time frame: within 6 hours after surgery

    Dichotomous yes/no outcome

  4. Late PONV

    Time frame: 6-24 hours after surgery

    Dichotomous yes/no outcome

  5. Visual Analogue Scale (VAS)

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

    VAS as a scale 0 - 10

  6. Visual Analogue Scale (VAS)

    Time frame: at the time of discharge from hospital (usually 24 hours after surgery)

    VAS as a scale 0 - 10

  7. Postoperative quality of recovery (QoR)

    Time frame: 24 hours after surgery

    QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)

  8. Post-Discharge Nausea and Vomiting (PDNV)

    Time frame: at 72 hours after surgery

    evaluated by telephone by Dichotomous yes/no outcome

Other outcomes

  1. Surgical Site Infection

    Time frame: at follow-up (usually at 7 days after surgery)

    infection as defined by the surgeon) at the trocar's or the drainage tube sites.

  2. Itching or burning sensation

    Time frame: during injection of the dexamethasone

    as described by the patient as dichotomous outcome yes/no outcome

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2023
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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