Prevention of Nausea and Vomiting in Patients After Surgery
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexamethasone and aprepitant
Dexamethasone and ondansetron
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Dexamethasone,, Ondansetron, Aprepitant, PONV, Laparoscopic surgery
Eligibility Criteria
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
Sites / Locations
- Yeditepe University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group DA: Dexamethasone and aprepitant
Group DO: Dexamethasone and ondansetron
Arm Description
Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)
Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Nausea
The secondary outcome measure is incidence of nausea
Retching
The secondary outcome measure is incidence of retching
Vomiting
The secondary outcome measure is incidence of vomiting
Need of rescue antiemetic
The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.
Full Information
NCT ID
NCT02021851
First Posted
December 9, 2013
Last Updated
December 19, 2013
Sponsor
Yeditepe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02021851
Brief Title
Prevention of Nausea and Vomiting in Patients After Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Dexamethasone,, Ondansetron, Aprepitant, PONV, Laparoscopic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group DA: Dexamethasone and aprepitant
Arm Type
Active Comparator
Arm Description
Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)
Arm Title
Group DO: Dexamethasone and ondansetron
Arm Type
Placebo Comparator
Arm Description
Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and aprepitant
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and ondansetron
Primary Outcome Measure Information:
Title
Complete response
Description
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
Secondary Outcome Measure Information:
Title
Nausea
Description
The secondary outcome measure is incidence of nausea
Time Frame
One year
Title
Retching
Description
The secondary outcome measure is incidence of retching
Time Frame
One year
Title
Vomiting
Description
The secondary outcome measure is incidence of vomiting
Time Frame
One year
Title
Need of rescue antiemetic
Description
The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Opioid consumption
Description
Opioid consumption
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yeditepe University Hospital
City
Devlet Yolu, Ankara cad 102/104
State/Province
Kozyatagi ISTANBUL
ZIP/Postal Code
34752
Country
Turkey
12. IPD Sharing Statement
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Prevention of Nausea and Vomiting in Patients After Surgery
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