The Effect of MDZ on Movement During UIA Clipping

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

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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