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Safety of Remifentanil Infusion

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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

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Problem Drug: remifentanil Phase 4

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  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality
Study Start Date : February 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: ultiva,remifentanil,opioid,analgesic
Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
Drug: remifentanil
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



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303627


Locations
Turkey
Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology
Ankara, Turkey, 06110
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
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 of Results:
Responsible Party: derya özkan, MD consultant, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01303627     History of Changes
Other Study ID Numbers: DiskapiTRH
First Posted: February 25, 2011    Key Record Dates
Results First Posted: June 18, 2012
Last Update Posted: June 25, 2012
Last Verified: June 2012

Keywords provided by derya özkan, Diskapi Teaching and Research Hospital:
Remifentanil
Laryngeal mask airway removal
Hemodynamic changing
Infusion
Ureterorenoscopy

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics