Text Size

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
History of Changes
  Purpose

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 Intervention Phase
Urinary Tract Problem
 Drug: remifentanil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • 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)


Enrollment: 42
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: derya özkan, MD consultant, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01303627     History of Changes
Other Study ID Numbers: DiskapiTRH
Study First Received: February 24, 2011
Results First Received: January 30, 2012
Last Updated: June 15, 2012
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 23, 2013