Clinical trial NCT02021851: Prevention of Nausea and Vomiting in Patients After Surgery
Official title: THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: Dexamethasone,
Ondansetron
Aprepitant
PONV
Laparoscopic surgery
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete response
timeFrame: One year
Secondary outcomes:
measure: Nausea
timeFrame: One year
measure: Retching
timeFrame: One year
measure: Vomiting
timeFrame: One year
measure: Need of rescue antiemetic
timeFrame: One year
Other outcomes:
measure: Opioid consumption
timeFrame: One year
Locations:
city: Devlet Yolu, Ankara cad 102/104
country: Turkey
facility: Yeditepe University Hospital
state: Kozyatagi ISTANBUL
Study officials:
References: