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Safety of Remifentanil Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01303627
First received: February 24, 2011
Last updated: June 15, 2012
Last verified: June 2012

February 24, 2011
June 15, 2012
February 2011
March 2011   (final data collection date for primary outcome measure)
Smooth cLMA Removal Condition (Score 1) [ Time Frame: At the end of the surgery ] [ Designated as safety issue: Yes ]
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)
Better (successful) lma removal condition with remifentanil [ Time Frame: emergence from anesthesia and throughout the lma removal ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01303627 on ClinicalTrials.gov Archive Site
Not Provided
Hemodynamic change with remifentanil [ Time Frame: Emergence from anesthesia and throughout the extubation ] [ Designated as safety issue: Yes ]
Measure the mean arterial pressure (noninvasive) and heart rate within 5 minutes period
Not Provided
Not Provided
 
Safety of Remifentanil Infusion
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Urinary Tract Problem
Drug: remifentanil
1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
  • 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
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. Epub 2009 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01303627
DiskapiTRH
No
derya özkan, Diskapi Teaching and Research Hospital
Diskapi Teaching and Research Hospital
Not Provided
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
Diskapi Teaching and Research Hospital
June 2012

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