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Completed

NCT Number: NCT01491009

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.

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Key information

Conditions

Postoperative Cognitive Functions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Medicine Hospital

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

IV infusion

midazolam

Drug

IV infusion

Primary outcomes

  1. Degree of sedative efficiency

    Time frame: During cystoscopy procedure

    Bispectral Index (BIS) was used.

  2. Degree of cognitive functions

    Time frame: Postoperative 60 minutes

    mini-mental state examination(MMSE) test was used.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2010
First posted
Dec 13, 2011
Registry last updated
Dec 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.