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

NCT ID: NCT01491009

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Postoperative Cognitive Functions

Keywords

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Dexmedetomidine midazolam remifentanil mini-mental state examination monitored anaesthesia care cystoscopy sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Remifentanil

IV infusion

Intervention Type DRUG

Midazolam

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Hande Arpacı

Dr. at Department of Anaesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşe Arpacı, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Füsun Bozkırlı, M.D.

Role: STUDY_DIRECTOR

Gazi University

Locations

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Gazi University Faculty of Medicine Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GU-154

Identifier Type: -

Identifier Source: org_study_id