A Phase 4 interventional study of Dexamethasone and aprepitant and Dexamethasone and ondansetron in Postoperative Nausea and Vomiting, sponsored by Yeditepe University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-12-27.
Sponsored by Yeditepe University Hospital · Phase 4, Interventional, and Prevention
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.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's enrollment of 67 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
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Exclusion Criteria:
Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)
Drug: Dexamethasone and aprepitant
Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)
Drug: Dexamethasone and ondansetron
Drug pages: Dexamethasone · Aprepitant
Complete response
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.
Time frame: One year
Nausea
The secondary outcome measure is incidence of nausea
Time frame: One year
Retching
The secondary outcome measure is incidence of retching
Time frame: One year
Vomiting
The secondary outcome measure is incidence of vomiting
Time frame: One year
Need of rescue antiemetic
The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.
Time frame: One year
Opioid consumption
Opioid consumption
Time frame: One year
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone · Aprepitant
Postoperative Nausea and Vomiting →
Yeditepe University Hospital