The Effect of MDZ on Movement During UIA Clipping
Effects of Midazolam on the Occurrence of Intraoperative Movement in Patients Undergoing Unruptured Intracranial Aneurysm Clipping Surgery: a Prospective Randomized Controlled Trial
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedStudy Start
First participant enrolled
September 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 26, 2022
October 1, 2022
1 year
September 18, 2022
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intraoperative movement
Incidence
During microscopic surgery
Secondary Outcomes (6)
Motor evoked potential amplitude
immediately postoperative surgery
Motor evoked potential Latency
immediately postoperative surgery
Duration of mechanical ventilation time
End of surgery to extubation time
Duration of ICU stay
From date of ICU admission until the date of first discharge from ICU, assessed up to 1 week
Satisfaction score for intraoperative environment
immediately postoperative surgery
- +1 more secondary outcomes
Study Arms (2)
treatment group
EXPERIMENTALMidazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.
Control group
PLACEBO COMPARATORNormal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope.
Interventions
Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.
Normal saline (0.03 mg/ml/30 min) will administered during UIA clipping through microscope.
Eligibility Criteria
You may qualify if:
- Patients who undergo elective unruptured intracranial aneurysm clipping surgery
- American Society of Anesthesiologists grade 1,2,3
- age \> 18 year old
You may not qualify if:
- Refuse to participate to the study
- Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
- Allergic history of benzodiazepine
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang-Hoon Koo
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
September 18, 2022
First Posted
September 23, 2022
Study Start
September 29, 2022
Primary Completion
September 30, 2023
Study Completion
December 31, 2023
Last Updated
October 26, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share