Postoperative Nausea and Vomiting
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexamethasone Oral
Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.
DRUGDexamethasone
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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessors will be blinded to the group allocation.
Intervention model description
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 at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial.
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.
Exclusion criteria
* steroids or antiemetics within 1 week of surgery * chronic opioid therapy * history of allergy to any of the study drug * serum creatinine \> 1.4 mg/dl * liver enzymes \> triple the normal limits * pregnancy * patient refusal * and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire * laparoscopic surgery is converted to open surgery after enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea or vomiting (PONV) | 24 hours after surgery | incidecne of PONV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue antiemetic | 24 hours after surgery | need for rescue antiemetic for 24 hours after surgery (Dichotomous yes/no outcome) |
| 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 | within 2 hours at the time of discharge from PACU | On VAS scale as numerical outcome |
| Postoperative quality of recovery | after 24 hours at the time of discharge from the hospital | using the QoR-15 questionnaire |
| Post-Discharge Nausea and Vomiting (PDNV) | 72 hours after surgery. | evaluated by telephone as a binary outcome |
| VAS at the time of discharge from hospital | after 24 hours at the time of discharge from the hospital | On VAS scale as numerical outcome |
| Postoperative fatigue | after 24 hours at the time of discharge from the hospital | on a 10-point scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (at follow-up) | within 2 weeks - on the follow-up | as evaluated by the surgeon |
| Itching or burning sensation on dexamethasone injections | during injection of the dexamethoasone | Dichotomous yes/no outcome |
Countries
Egypt
Contacts
Primary ContactMoataz M Emara, MD, EDAIC
Outcome results
None listed