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Comparison of Remifentanil With Dexmedetomidine or Midazolam in Regards of Sedation Effectivity and Postoperative Cognitive Functions in Cystoscopies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491009
First Posted: December 13, 2011
Last Update Posted: December 13, 2011
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.
Information provided by (Responsible Party):
Ayşe Hande Arpacı, Gazi University
  Purpose
The aim of the study was to compare the effects of remifentanil-dexmedetomidine and remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia care (MAC) patients undergoing cystoscopy.

Condition Intervention
Postoperative Cognitive Functions Drug: Remifentanil Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ayşe Hande Arpacı, Gazi University:

Primary Outcome Measures:
  • Degree of sedative efficiency [ Time Frame: During cystoscopy procedure ]
    Bispectral Index (BIS) was used.

  • Degree of cognitive functions [ Time Frame: Postoperative 60 minutes ]
    mini-mental state examination(MMSE) test was used.


Enrollment: 40
Study Start Date: May 2006
Study Completion Date: November 2010
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Remifentanil
    IV infusion
    Drug: Midazolam
    IV infusion
Detailed Description:
Forty patients undergoing cystoscopy receiving remifentanil infusion of 0.05 microgram per kg-1 min-1 were randomized into two groups: Either dexmedetomidine 1 microgram per kg -1 (GroupD) or midazolam 0.2 mg kg-1h-1 (GroupM) were administered intravenously for the first 10 minutes. Subsequently anesthesia was maintained by using the bispectral index(BIS) as a continuous infusion of dexmedetomidine 0.2-0.7 microgram per kg-1h-1 or midazolam 0.05-0.15 mgkg-1h-1. Heart rate, mean arterial pressure, MMSE, sedation and the patient's and surgeon's satisfaction were determined.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with indication of cystoscopy must be able to have sedation

Exclusion Criteria:

  • hypersensitivity to drugs used
  • morbid obesity
  • coronary disease
  • diabetes mellitus and other endocrinologic diseases
  • pregnancy
  • psychomotor diseases
  Contacts and Locations
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): NCT01491009


Locations
Turkey
Gazi University Faculty of Medicine Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Gazi University
Investigators
Principal Investigator: Ayşe Arpacı, M.D. Gazi University
Study Director: Füsun Bozkırlı, M.D. Gazi University
  More Information

Responsible Party: Ayşe Hande Arpacı, Dr. at Department of Anaesthesiology and Reanimation, Gazi University
ClinicalTrials.gov Identifier: NCT01491009     History of Changes
Other Study ID Numbers: GU-154
First Submitted: December 6, 2011
First Posted: December 13, 2011
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by Ayşe Hande Arpacı, Gazi University:
Dexmedetomidine
midazolam
remifentanil
mini-mental state examination
monitored anaesthesia care
cystoscopy
sedation

Additional relevant MeSH terms:
Dexmedetomidine
Midazolam
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Analgesics, Opioid
Narcotics