Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting, Postoperative Pain
Conditions
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. 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.
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: 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.
Interventions
DRUGAt-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.
DRUGAt-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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The pharmacists will prepare the study drug, either dexamethasone or saline in 10 mL similar syringes, according to the allocation. The syringe will be labeled with the patient's name and the allocation group, A or B. The study participants, caregivers, data collectors, and data analysts will all be blinded. The pharmacists will not participate in the study.
Intervention model description
This is a randomized controlled trial superiority parallel trial. This is a pilot trial and the sample size will be updated after the pilot study completion and the approval of the local Institutional Review Board (IRB).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea or vomiting (PONV) | 24 hours after surgery | incidence of PONV (binary outcome as yes/No) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Visual Analogue Scale (VAS) | at the time of discharge from PACU (usually at 2 hours after surgery) | VAS as a scale 0 - 10 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed