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

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ClinicalTrials.gov Identifier: NCT01491009
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Ayşe Hande Arpacı, Gazi University

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Cognitive Functions Drug: Remifentanil Drug: Midazolam Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Remifentanil
    IV infusion
  • Drug: Midazolam
    IV infusion


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

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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
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

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
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Turkey
Gazi University Faculty of Medicine Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Ayşe Arpacı, M.D. Gazi University
Study Director: Füsun Bozkırlı, M.D. Gazi University
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Responsible Party: Ayşe Hande Arpacı, Dr. at Department of Anaesthesiology and Reanimation, Gazi University
ClinicalTrials.gov Identifier: NCT01491009    
Other Study ID Numbers: GU-154
First Posted: December 13, 2011    Key Record Dates
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:
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Midazolam
Remifentanil
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents