Prevention of Nausea and Vomiting in Patients After Surgery

Yeditepe University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Dexamethasone and ondansetron; Drug: Dexamethasone and aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT02021851

125

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 2 patient groups, including a placebo group

Group DA: Dexamethasone and aprepitant

Active Comparator group

Description:

Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)

Treatment:

Drug: Dexamethasone and aprepitant

Group DO: Dexamethasone and ondansetron

Placebo Comparator group

Description:

Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)

Treatment:

Drug: Dexamethasone and ondansetron