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

Not Applicable

• Conditions: Anesthesia, Spinal; Sedation
• Interventions: Drug: Propofol; Drug: Midazolam; Drug: Dexmedetomidine

• Registration Number: NCT03399019
• Lead Sponsor: Hallym University Medical Center

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.

Study Timeline

• Study Start: 2016-09-05
• Study First Submitted: 2017-01-02
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-07
• Last Update Submitted: 2018-01-07
• Study First Posted: 2018-01-16
• Last Update Posted: 2018-01-16
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	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
Midazolam	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
Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
correlation between BIS and OAA/S (observer's assessment of alertness/sedation) score	1 day	Statistically 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 Outcome Measures

Name	Time	Method
The amount of rescue analgesics (fentanyl in mg) and rescue hypnotic (propofol in mg)	1 day	The 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

Trial Locations

Locations (1)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of