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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01491009
Enrollment
40
Registered
2011-12-13
Start date
2006-05-31
Completion date
2010-11-30
Last updated
2011-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Functions

Keywords

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

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.

Interventions

DRUGRemifentanil

IV infusion

DRUGMidazolam

IV infusion

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Degree of sedative efficiencyDuring cystoscopy procedureBispectral Index (BIS) was used.
Degree of cognitive functionsPostoperative 60 minutesmini-mental state examination(MMSE) test was used.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026