This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Ayşe Hande Arpacı, Gazi University Identifier:
First received: December 6, 2011
Last updated: December 12, 2011
Last verified: December 2011
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01491009

Gazi University Faculty of Medicine Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Gazi University
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 Identifier: NCT01491009     History of Changes
Other Study ID Numbers: GU-154
Study First Received: December 6, 2011
Last Updated: December 12, 2011

Keywords provided by Ayşe Hande Arpacı, Gazi University:
mini-mental state examination
monitored anaesthesia care

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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
GABA Modulators
GABA Agents
Analgesics, Opioid
Narcotics processed this record on September 21, 2017