Prevention of Nausea and Vomiting in Patients After Surgery
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|ClinicalTrials.gov Identifier: NCT02021851|
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: Dexamethasone and aprepitant Drug: Dexamethasone and ondansetron||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 Start Date :||July 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: Group DA: Dexamethasone and aprepitant
Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)
Drug: Dexamethasone and aprepitant
Placebo Comparator: Group DO: Dexamethasone and ondansetron
Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)
Drug: Dexamethasone and ondansetron
- Complete response [ Time Frame: 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.
- Nausea [ Time Frame: One year ]The secondary outcome measure is incidence of nausea
- Retching [ Time Frame: One year ]The secondary outcome measure is incidence of retching
- Vomiting [ Time Frame: One year ]The secondary outcome measure is incidence of vomiting
- Need of rescue antiemetic [ Time Frame: One year ]The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.
- Opioid consumption [ Time Frame: One year ]Opioid consumption
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021851
|Yeditepe University Hospital|
|Devlet Yolu, Ankara cad 102/104, Kozyatagi ISTANBUL, Turkey, 34752|