Intraoperative Movement
Conditions
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.
Interventions
DRUGMidazolam
Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.
DRUGNormal saline
Normal saline (0.03 mg/ml/30 min) will administered during UIA clipping through microscope.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative movement | During microscopic surgery | Incidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor evoked potential Latency | immediately postoperative surgery | Latency |
| Duration of mechanical ventilation time | End of surgery to extubation time | duration |
| 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) |
| Postoperative delirium | Postoperative 24 hour | Incidence |
| 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 |
Countries
South Korea
Contacts
Primary ContactChang-Hoon Koo
Outcome results
None listed