The Effect of MDZ on Movement During UIA Clipping

NCT ID: NCT05553678

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-29

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intraoperative Movement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

treatment group

Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.

Control group

Normal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline (0.03 mg/ml/30 min) will administered during UIA clipping through microscope.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Midazolam

Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.

Intervention Type DRUG

Normal saline

Normal saline (0.03 mg/ml/30 min) will administered during UIA clipping through microscope.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chang-Hoon Koo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chang-Hoon Koo

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chang-Hoon Koo

Role: CONTACT

+821085098841

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chang-Hoon Koo

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UIA-MDZ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brain Tumor Surgery and Postoperative Delirium
NCT06863064 NOT_YET_RECRUITING NA