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Clinical Trials/NCT01491009
NCT01491009
Completed
Not Applicable

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

Gazi University1 site in 1 country40 target enrollmentMay 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Cognitive Functions
Sponsor
Gazi University
Enrollment
40
Locations
1
Primary Endpoint
Degree of sedative efficiency
Status
Completed
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
November 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ayşe Hande Arpacı

Dr. at Department of Anaesthesiology and Reanimation

Gazi University

Eligibility 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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