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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:
Information provided by (Responsible Party):
Ayşe Hande Arpacı, Gazi University
ClinicalTrials.gov Identifier:
NCT01491009
First received: December 6, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gazi University:

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

  • Degree of cognitive functions [ Time Frame: Postoperative 60 minutes ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 6, 2011
Last Updated: December 12, 2011
Health Authority: Turkey: Gazi University Faculty of Medicine Department of Anesthesiology and Reanimation

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

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

ClinicalTrials.gov processed this record on May 23, 2013