Postoperative Nausea and Vomiting
Conditions
Keywords
Dexamethasone,, Ondansetron, Aprepitant, PONV, Laparoscopic surgery
Brief summary
Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery. Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia. PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P\<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery.
Interventions
DRUGDexamethasone and aprepitant
Sponsors
Yeditepe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18 Years to 60 Years * ASA (American Society of Anesthesiologist) physical status I or II * Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy
Exclusion criteria
* Hypersensitivity or contraindication to the study medications, * Antiemetic drug or steroid use within 24 hours before anesthesia, * History of diabetes mellitus, * History of motion sickness or postoperative nausea and vomiting, * Pregnancy, * Breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | One year | The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea | One year | The secondary outcome measure is incidence of nausea |
| Retching | One year | The secondary outcome measure is incidence of retching |
| Vomiting | One year | The secondary outcome measure is incidence of vomiting |
| Need of rescue antiemetic | One year | The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | One year | Opioid consumption |
Countries
Turkey (Türkiye)
Outcome results
None listed