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Safety of Remifentanil Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303627
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : June 18, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital

Tracking Information
First Submitted Date  ICMJE February 24, 2011
First Posted Date  ICMJE February 25, 2011
Results First Submitted Date  ICMJE January 30, 2012
Results First Posted Date  ICMJE June 18, 2012
Last Update Posted Date June 25, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
Better (successful) LMA removal condition with remifentanil [ Time Frame: Emergence from anesthesia and throughout the lma removal ]
When LMA removal was accomplished without coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, desaturation to SpO2 <90%, it was considered a smooth (successful)(score 1) removal. If not it was considered a unsuccessful (score 2) removal.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
Hemodynamic change with remifentanil [ Time Frame: Emergence from anesthesia and throughout the extubation ]
Measure the mean arterial pressure (noninvasive) and heart rate within 5 minutes period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Remifentanil Infusion
Official Title  ICMJE The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urinary Tract Problem
Intervention  ICMJE Drug: remifentanil
1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
Study Arms  ICMJE
  • Active Comparator: ultiva,remifentanil,opioid,analgesic
    Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
    Intervention: Drug: remifentanil
  • No Intervention: control
    Control:Remifentanil stopped at the end of the surgery
Publications * Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2012)
42
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2011)
40
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303627
Other Study ID Numbers  ICMJE DiskapiTRH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party derya özkan, Diskapi Teaching and Research Hospital
Study Sponsor  ICMJE Diskapi Teaching and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Diskapi Teaching and Research Hospital
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP