- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303627
Safety of Remifentanil Infusion
June 15, 2012 updated by: derya özkan, Diskapi Teaching and Research Hospital
The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality
The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.
Study Overview
Detailed Description
In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane .
Throughout the surgery hemodynamic parameters are going to be recorded.
As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA.
During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06110
- Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I-II status
- aged 18-60 years old
- presenting for ureterorenoscopy
Exclusion Criteria:
- history of hypertension
- asthma and chronic obstructive lung disease
- recent respiratory tract infections
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ultiva,remifentanil,opioid,analgesic
Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
|
1-4 ng/mL i.v.
infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
|
No Intervention: control
Control:Remifentanil stopped at the end of the surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smooth cLMA Removal Condition (Score 1)
Time Frame: At the end of the surgery
|
cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed.
If any of these compli- cations was observed it was regarded as unsuccessful (score 2)
|
At the end of the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jülide Ergil, MD, Ministry of Health Dıskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1.
- Study Chair: Alp Alptekin, MD, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1
- Study Chair: Nihan Aktürk, MD, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital , Anesthesiology 1
- Study Chair: Haluk Gümüs, MD, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
February 24, 2011
First Submitted That Met QC Criteria
February 24, 2011
First Posted (Estimate)
February 25, 2011
Study Record Updates
Last Update Posted (Estimate)
June 25, 2012
Last Update Submitted That Met QC Criteria
June 15, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiskapiTRH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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