Clinical trial NCT03399019: Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia
Official title: Usefulness of Bispectal Index (BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia : a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedation
Anesthesia, Spinal
Keywords: Bispectral index monitor
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study compares to the same intervention (monitor BIS scores and OAA/S scores timely) between all of three sedative drugs.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: correlation between BIS and OAA/S (observer's assessment of alertness/sedation) score
timeFrame: 1 day
Secondary outcomes:
measure: The amount of rescue analgesics (fentanyl in mg) and rescue hypnotic (propofol in mg)
timeFrame: 1 day
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
Study officials:
affiliation: Hallym University Medical Center
name: Soo Kyung Lee, M.D
role: STUDY_DIRECTOR
References:
citation: Kato T, Koitabashi T, Ouchi T, Serita R. The utility of bispectral index monitoring for sedated patients treated with low-dose remifentanil. J Clin Monit Comput. 2012 Dec;26(6):459-63. doi: 10.1007/s10877-012-9379-4. Epub 2012 Jul 25.
citation: Venn RM, Grounds RM. Comparison between dexmedetomidine and propofol for sedation in the intensive care unit: patient and clinician perceptions. Br J Anaesth. 2001 Nov;87(5):684-90. doi: 10.1093/bja/87.5.684.
citation: Kasuya Y, Govinda R, Rauch S, Mascha EJ, Sessler DI, Turan A. The correlation between bispectral index and observational sedation scale in volunteers sedated with dexmedetomidine and propofol. Anesth Analg. 2009 Dec;109(6):1811-5. doi: 10.1213/ANE.0b013e3181c04e58.