Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

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.

• 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

• postoperative nausea or vomiting (PONV) [24 hours after surgery]: incidence of PONV (binary outcome as yes/No)

Secondary outcomes

• The need for rescue antiemetic [24 hours after surgery]: Dichotomous yes/no outcome
• The need for rescue analgesia [24 hours after surgery]: Dichotomous yes/no outcome
• Postoperative Care Unit (PACU) and Early PONV [within 6 hours after surgery]: Dichotomous yes/no outcome
• Late PONV [6-24 hours after surgery]: Dichotomous yes/no outcome
• Visual Analogue Scale (VAS) [at the time of discharge from PACU (usually at 2 hours after surgery)]: VAS as a scale 0 - 10
• Visual Analogue Scale (VAS) [at the time of discharge from hospital (usually 24 hours after surgery)]: VAS as a scale 0 - 10
• Postoperative quality of recovery (QoR) [24 hours after surgery]: QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)
• Post-Discharge Nausea and Vomiting (PDNV) [at 72 hours after surgery]: evaluated by telephone by Dichotomous yes/no outcome

Other outcomes

• Surgical Site Infection [at follow-up (usually at 7 days after surgery)]: infection as defined by the surgeon) at the trocar's or the drainage tube sites.
• Itching or burning sensation [during injection of the dexamethasone]: as described by the patient as dichotomous outcome yes/no outcome

Sex: All, ages: 18 Years to any

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.

• Moataz M Emara, MD, EDAIC, Study chair, Mansoura University Faculty of Medicine