Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy
Study Details
Study Description
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.
We will start a pilot randomized controlled study to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
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:
We will perform 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: At-night dexamethasone 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
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.
|
| Active Comparator: At-induction dexamethasone 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
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.
|
Outcome Measures
Primary Outcome Measures
- postoperative nausea or vomiting (PONV) [24 hours after surgery]
incidence of PONV (binary outcome as yes/No)
Secondary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mansoura University
Investigators
- Study Chair: Moataz M Emara, MD, EDAIC, Mansoura University Faculty of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R.23.07.2239