Comparison of Remifentanil With Dexmedetomidine or Midazolam in Regards of Sedation Effectivity and Postoperative Cognitive Functions in Cystoscopies
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Degree of sedative efficiency [ Time Frame: During cystoscopy procedure ] [ Designated as safety issue: Yes ]Bispectral Index (BIS) was used.
- Degree of cognitive functions [ Time Frame: Postoperative 60 minutes ] [ Designated as safety issue: Yes ]mini-mental state examination(MMSE) test was used.
|Study Start Date:||May 2006|
|Study Completion Date:||November 2010|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491009
|Gazi University Faculty of Medicine Hospital|
|Ankara, Turkey, 06100|
|Principal Investigator:||Ayşe Arpacı, M.D.||Gazi University|
|Study Director:||Füsun Bozkırlı, M.D.||Gazi University|