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The Effect of MDZ on Movement During UIA Clipping

Seoul National University logo

Seoul National University

Status and phase

Enrolling
Phase 4

Conditions

Intraoperative Movement

Treatments

Drug: Normal saline
Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT05553678
UIA-MDZ

Details and patient eligibility

About

This study is a randomized, controlled, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery.

Enrollment

64 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who undergo elective unruptured intracranial aneurysm clipping surgery
  • American Society of Anesthesiologists grade 1,2,3
  • age > 18 year old

Exclusion criteria

  • Refuse to participate to the study
  • Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
  • Allergic history of benzodiazepine
  • Pregnant

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

64 participants in 2 patient groups, including a placebo group

treatment group
Experimental group
Description:
Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.
Treatment:
Drug: Midazolam
Control group
Placebo Comparator group
Description:
Normal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope.
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Central trial contact

Chang-Hoon Koo

Data sourced from clinicaltrials.gov

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