Prevention of Nausea and Vomiting in Patients After Surgery

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021851
• Other study ID #: 125
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2013
• Last updated: December 19, 2013
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2013
• Source: Yeditepe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Yeditepe University Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone and aprepitant

• Dexamethasone and ondansetron

Locations

Country	Name	City	State
Turkey	Yeditepe University Hospital	Devlet Yolu, Ankara cad 102/104	Kozyatagi ISTANBUL

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opioid consumption	Opioid consumption	One year	No
Primary	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.	One year	No
Secondary	Nausea	The secondary outcome measure is incidence of nausea	One year	No
Secondary	Retching	The secondary outcome measure is incidence of retching	One year	No
Secondary	Vomiting	The secondary outcome measure is incidence of vomiting	One year	No
Secondary	Need of rescue antiemetic	The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.	One year	No