The Effect of MDZ on Movement During UIA Clipping

Phase 4

Recruiting

• Conditions: Intraoperative Movement
• Interventions: Drug: Normal saline; Drug: Midazolam

• Registration Number: NCT05553678
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-18
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Start: 2022-09-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Normal saline	Normal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope.
treatment group	Midazolam	Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.

Primary Outcome Measures

Name	Time	Method
Intraoperative movement	During microscopic surgery	Incidence

Secondary Outcome Measures

Name	Time	Method
Motor evoked potential amplitude	immediately postoperative surgery	amplitude
Satisfaction score for intraoperative environment	immediately postoperative surgery	using 11-point score (0=worst dissatisfied, 10=very sattisfied)
Motor evoked potential Latency	immediately postoperative surgery	Latency
Duration of ICU stay	From date of ICU admission until the date of first discharge from ICU, assessed up to 1 week	duration of ICU stay, day
Duration of mechanical ventilation time	End of surgery to extubation time	duration
Postoperative delirium	Postoperative 24 hour	Incidence

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of