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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-05

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sedation Anesthesia, Spinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dexmedetomidine

Dexmedetomidine

: initial loading 0.5- 1 mng/kg for 10 minutes and maintenance 0.2-0.7mng/kg/hr

Check BIS (bispectral index) score and OAA/S (Observer assessment of alertness/sedation score) by time

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Propofol

Propofol

: 0.75-3 mg/kr/hr continous infusion Check BIS (bispectral index) score and OAA/S (Observer assessment of alertness/sedation score) by time

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Midazolam

Midazolam

: initial loading 0.5- 1 mng/kg for 10 minutes and maintenance 0.2-0.7mng/kg/hr

Check BIS (bispectral index) score and OAA/S (Observer assessment of alertness/sedation score) by time

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No