Prevention of Nausea and Vomiting in Patients After Surgery

NCT02021851 | Completed Phase 4

• 1 other identifier: 125
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Dexamethasone,; Ondansetron; Aprepitant; PONV; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Nausea

  One year

• Retching

  One year

• Vomiting

  One year

• Need of rescue antiemetic

  One year

Other Outcomes (1)

• Opioid consumption

  One year

Study Arms (2)

Group DA: Dexamethasone and aprepitant

ACTIVE COMPARATOR

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

Drug: Dexamethasone and aprepitant

Group DO: Dexamethasone and ondansetron

PLACEBO COMPARATOR

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

Drug: Dexamethasone and ondansetron

Interventions

Dexamethasone and aprepitant DRUG

Group DA: Dexamethasone and aprepitant

Dexamethasone and ondansetron DRUG

Group DO: Dexamethasone and ondansetron

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Years to 60 Years
• ASA (American Society of Anesthesiologist) physical status I or II
• Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University Hospital: lead

Study Sites (1)

Yeditepe University Hospital

Devlet Yolu, Ankara Cad 102/104, Kozyatagi Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Aprepitant; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 27, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 27, 2013

Record last verified: 2013-12

Locations

TU (1)