The Effect of MDZ on Movement During UIA Clipping

October 25, 2022 updated by: Chang-Hoon Koo, Seoul National University Hospital

Effects of Midazolam on the Occurrence of Intraoperative Movement in Patients Undergoing Unruptured Intracranial Aneurysm Clipping Surgery: a Prospective Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative movement
Time Frame: During microscopic surgery
Incidence
During microscopic surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 18, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIA-MDZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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