Faculty of Medicine
Al Mansurah, Aldakahlia, 35516, Egypt
NCT Number: NCT05998317
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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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Al Mansurah, Aldakahlia, 35516, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 24 hours after surgery
incidence of PONV (binary outcome as yes/No)
Time frame: 24 hours after surgery
Dichotomous yes/no outcome
Time frame: 24 hours after surgery
Dichotomous yes/no outcome
Time frame: within 6 hours after surgery
Dichotomous yes/no outcome
Time frame: 6-24 hours after surgery
Dichotomous yes/no outcome
Time frame: at the time of discharge from PACU (usually at 2 hours after surgery)
VAS as a scale 0 - 10
Time frame: at the time of discharge from hospital (usually 24 hours after surgery)
VAS as a scale 0 - 10
Time frame: 24 hours after surgery
QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)
Time frame: at 72 hours after surgery
evaluated by telephone by Dichotomous yes/no outcome
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.
Time frame: during injection of the dexamethasone
as described by the patient as dichotomous outcome yes/no outcome
Mansoura University
Other
Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
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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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