Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.
Background: Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before 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 oral administration. Methods: This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with 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 of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial. Discussion: The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. Additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
814
Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.
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 sensations in injection.
Mansoura University Faculty of Medicine
Al Mansurah, Aldakahlia, Egypt
RECRUITINGPostoperative nausea or vomiting (PONV)
incidecne of PONV
Time frame: 24 hours after surgery
Rescue antiemetic
need for rescue antiemetic for 24 hours after surgery (Dichotomous yes/no outcome)
Time frame: 24 hours after surgery
Early PONV
(Dichotomous yes/no outcome)
Time frame: within 6 hours after surgery
Late PONV
(Dichotomous yes/no outcome)
Time frame: 6 - 24 hours after surgery
Visual Analogue Scale (VAS) at the time of discharge from PACU
On VAS scale as numerical outcome
Time frame: within 2 hours at the time of discharge from PACU
VAS at the time of discharge from hospital
On VAS scale as numerical outcome
Time frame: after 24 hours at the time of discharge from the hospital
Postoperative fatigue
on a 10-point scale
Time frame: after 24 hours at the time of discharge from the hospital
Postoperative quality of recovery
using the QoR-15 questionnaire
Time frame: after 24 hours at the time of discharge from the hospital
Post-Discharge Nausea and Vomiting (PDNV)
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evaluated by telephone as a binary outcome
Time frame: 72 hours after surgery.