NCT01491009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

December 6, 2011

Last Update Submit

December 12, 2011

Conditions

Postoperative Cognitive Functions

Keywords

Dexmedetomidinemidazolamremifentanilmini-mental state examinationmonitored anaesthesia carecystoscopysedation

Outcome Measures

Primary Outcomes (2)

  • Degree of sedative efficiency

    Bispectral Index (BIS) was used.

    During cystoscopy procedure

  • Degree of cognitive functions

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

    Postoperative 60 minutes

Interventions

RemifentanilDRUG

IV infusion

MidazolamDRUG

IV infusion

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with indication of cystoscopy must be able to have sedation

You may not qualify if:

  • hypersensitivity to drugs used
  • morbid obesity
  • coronary disease
  • diabetes mellitus and other endocrinologic diseases
  • pregnancy
  • psychomotor diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Medicine Hospital

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

RemifentanilMidazolam

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ayşe Arpacı, M.D.

    Gazi University

    PRINCIPAL INVESTIGATOR

  • Füsun Bozkırlı, M.D.

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. at Department of Anaesthesiology and Reanimation

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 13, 2011

Study Start

May 1, 2006

Primary Completion

February 1, 2007

Study Completion

November 1, 2010

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

TU(1)