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Prevention of Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
dexamethasone ondansetron
Dexamethasone dimenhidrinate
Sponsored by
Yeditepe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Criteria:

Inclusion Criteria:

18 Years to 60 Years woman

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

  • Turkey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dexamethasone and ondansetron

dexamethasone and dimenhydrinate

Arm Description

dexamethasone 8 mg with ondansetron 4mg administered in group DO

dexamethasone 8 mg with dimenhydrinate 1mg/kg administered in group DD

Outcomes

Primary Outcome Measures

prevention of postoperative nausea and vomiting
The primary outcome is complete response: complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2015
Last Updated
November 20, 2017
Sponsor
Yeditepe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02382146
Brief Title
Prevention of Postoperative Nausea and Vomiting
Official Title
A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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
We designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with dimenhydrinate undergoing plastic surgery.
Detailed Description
A total of 60 voman patient, ASA status I-II , aged 18-65 year and scheduled for elective rhinoplasty were enrolled in the study. Exclusion criterias hypersensitivity or contraindication for the studied medications, received an antiemetic drug or steroid within 24 hours before anesthesia, have history of diabetes history of motion sickness (MS) or PONV, or pregnant and lactating females. Patients were informed on how to use the patient controlled analgesia device during the postoperative period. The risk criterias for PONV were recorded for each patient.Patients were randomly assigned to two study groups of 30 patients. All patients were premedicated with intravenous (iv) midazolam (1-2 mg). On arrival in the operating room, standard anesthetic monitors were applied. Anesthesia was induced with iv propofol (2-3 mg/kg) and fentanyl (1-1.5 μg/kg). Tracheal intubation was facilitated with rocuronium (0.6 mg/kg). After tracheal intubation all patient received iv 8 mg dexamethasone. Normocapnic mechanical ventilation was performed after intubation. General anesthesia was maintained with sevoflurane (1 minimum alveolar concentration) in oxygen / air mixture and remifentanil (0.1-0.3 μg/kg/min) infusion.Four mg ondansetron and for each patient 1 mg/kg dimenhydrinate in the 5 ml syringe solution were prepared by pharmacy department, and given to the blinded investigators. The patients, anesthesiologists (with the exception of the primary author), statistician, and observes were all blinded. Dimenhydrinate was administered in group DD (1mg/kg), and ondansetron was administered in group DO (4mg), and all patients received tramadol (1.5mg/kg) and tenoksikam (20mg) half an hour before emergence. Postoperative analgesia was provided with a patient controlled analgesia system by using iv tramadol (5mg/mL) (2 ml bolus and 10 minutes lockout interval without basal infusion). After the surgery, muscle relaxation was reversed by administering neostigmine (0.05mg/kg) and atropine (0.015mg/kg). Patients were extubated and transferred to the recovery unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone and ondansetron
Arm Type
Experimental
Arm Description
dexamethasone 8 mg with ondansetron 4mg administered in group DO
Arm Title
dexamethasone and dimenhydrinate
Arm Type
Active Comparator
Arm Description
dexamethasone 8 mg with dimenhydrinate 1mg/kg administered in group DD
Intervention Type
Drug
Intervention Name(s)
dexamethasone ondansetron
Other Intervention Name(s)
dekort zofer dramamine
Intervention Description
dexamethasone 8 mg intravenous ondansetron 4 mg intravenous dimenhydrinate 1mg/kg intravenous
Intervention Type
Drug
Intervention Name(s)
Dexamethasone dimenhidrinate
Other Intervention Name(s)
dekort dramamin
Intervention Description
dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous
Primary Outcome Measure Information:
Title
prevention of postoperative nausea and vomiting
Description
The primary outcome is complete response: complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria: Inclusion Criteria: 18 Years to 60 Years woman 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nurcan kızılcık
Organizational Affiliation
yeditepe UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turkey
City
Istanbul
State/Province
Kadıkoy
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

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Prevention of Postoperative Nausea and Vomiting

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