Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
Primary Purpose
Incidence of Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Neostigmine
sugammadex
Sponsored by
About this trial
This is an interventional prevention trial for Incidence of Postoperative Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- endotracheal intubation and general anesthesia scheduled for elective surgery
Exclusion Criteria:
- age < 18 years, > 65 years
- pregnancy
- refusal to participate and patients already participating in another study
- allergy to study drugs
- communication difficulty
- psychiatric and neurological disorders
- use of analgesics or sedative or antiemetic drugs within 24 hours before surgery.
- emergency surgery
- history of drug or alcohol abuse
- ASA 3 and above
- patients with vertigo
- Laparoscopic surgery, oncologic surgery, strabismus and mid ear surgery neurosurgery, gynecologic surgery, breast surgery
Sites / Locations
- Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
neostigmine
sugammadex
Arm Description
Outcomes
Primary Outcome Measures
Verbal Descriptive Scale
0: no nausea 1: mild 2: moderate 3: severe
Secondary Outcome Measures
Full Information
NCT ID
NCT02286752
First Posted
November 3, 2014
Last Updated
January 11, 2015
Sponsor
T.C. ORDU ÜNİVERSİTESİ
1. Study Identification
Unique Protocol Identification Number
NCT02286752
Brief Title
Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ
4. Oversight
5. Study Description
Brief Summary
Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting.
It has been suggest that antagonism of residual neuromuscular block with a mixture of neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea and vomiting.
Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse effects include slight coughing, movement, an altered taste sensation in the mouth, transient prolongation of the QT interval, hypersensitivity, and a short term prolongation of the activated partial thromboplastin time.
The aim of this study was to compare the sugammadex versus neostigmine plus atropine for reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative nausea and vomiting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incidence of Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neostigmine
Arm Type
Active Comparator
Arm Title
sugammadex
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine
Intervention Type
Drug
Intervention Name(s)
sugammadex
Intervention Description
for reversal of neuromuscular block: sugammadex 2 mg kg-1
Primary Outcome Measure Information:
Title
Verbal Descriptive Scale
Description
0: no nausea 1: mild 2: moderate 3: severe
Time Frame
within postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status 1 and 2
endotracheal intubation and general anesthesia scheduled for elective surgery
Exclusion Criteria:
age < 18 years, > 65 years
pregnancy
refusal to participate and patients already participating in another study
allergy to study drugs
communication difficulty
psychiatric and neurological disorders
use of analgesics or sedative or antiemetic drugs within 24 hours before surgery.
emergency surgery
history of drug or alcohol abuse
ASA 3 and above
patients with vertigo
Laparoscopic surgery, oncologic surgery, strabismus and mid ear surgery neurosurgery, gynecologic surgery, breast surgery
Facility Information:
Facility Name
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
City
Altınordu
State/Province
Ordu
ZIP/Postal Code
52100
Country
Turkey
12. IPD Sharing Statement
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Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
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