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Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia

Usefulness of Bispectal Index (BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia : a Prospective Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03399019
Acronym
BIS
Enrollment
45
Registered
2018-01-16
Start date
2016-09-05
Completion date
2018-03-31
Last updated
2018-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal, Sedation

Keywords

Bispectral index monitor

Brief summary

This study is to investigate on the objective relevance between bispectral index (BIS) and Observer's assessment of alertness/sedation (OAA/S) scale in patients sedated with Midazolam, propofol and dexmedetomidine during spinal anesthesia. Also, we will evaluate the reflection of actual sedation levels on BIS monitoring.

Detailed description

Sedation is an important element of regional anesthesia during surgery, which allows to finish surgery smoothly by reducing patients' anxiety and fear who undergo regional and local anesthesia. If adequate sedation is not maintained during regional anesthesia, surgery may be disturbed by patient's movement. This can cause the patient to be physically and mentally stressed with discomfort. Commonly used measurement to determine the adequate sedation level relies on subjective physician's assessment such as scoring for response to talk, shake and pain. This measurement is unreliable and not continuous. Recently, BIS is used to guide sedation during spinal anesthesia as an objective monitoring method in many studies. but previous studies result contrasting in the correlation between BIS and sedation levels with lack in evaluation between sedative drugs. In this study, the investigators will investigate the usefullness of BIS monitoring during regional anesthesia with sedation and evaluate the suitability of correlation BIS and OAA/S between drugs (midazolam, propofol and dexmedetomidine). The anesthetic and sedation protocol will be standardized.

Interventions

DRUGDexmedetomidine

initial loading dose (0.5 \ 1㎍/kg for 10 minutes) and maintenance infusion (0.2-0.7㎍/kg/hr)

DRUGPropofol

continuous infusion (0.75-3mg/kg/hr)

DRUGMidazolam

0.05mg/kg bolus injection and if not OAA/S ≤ 3 within 5 minutes, add 0.01mg/kg at intervals of 1\ 2 minutes

Sponsors

Hallym University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

This study compares to the same intervention (monitor BIS scores and OAA/S scores timely) between all of three sedative drugs.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients who scheduled for knee arthroscopic surgery under spinal anesthesia

Exclusion criteria

* Patients with a history of hepatic, renal, cardiovascular disease, and those who have allergy to study drugs (dexmedetomidine, propofol, midazolam). * Hemodynamically unstable patients. * Patients who is noncommunicative.

Design outcomes

Primary

MeasureTime frameDescription
correlation between BIS and OAA/S (observer's assessment of alertness/sedation) score1 dayStatistically significant (p\<0.05) correlations between BIS (range of 0-100) and OAA/S scale (range of 1-5) in dexmedetomidine, propofol and midazolam.

Secondary

MeasureTime frameDescription
The amount of rescue analgesics (fentanyl in mg) and rescue hypnotic (propofol in mg)1 dayThe amount of rescue hypnotics due to insufficient sedation (total additional volume of propofol in mg) and rescue analgesics (total additional volume of fentanyl in mng) due to insufficient pain control

Countries

South Korea

Contacts

Primary ContactYi Hwa Choi, M.D
pcyhchoi@hallym.or.kr+82-31-380-3945
Backup ContactSoo Kyung Lee, M.D
agneta@hallym.or.kr+82-31-380-3945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026