Usefulness of Bispectal Index (BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia : a Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- correlation between BIS and OAA/S (observer's assessment of alertness/sedation) score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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
Intervention: Dexmedetomidine (Drug)
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
Intervention: Propofol (Drug)
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
Intervention: Midazolam (Drug)
Outcomes
Primary Outcomes
correlation between BIS and OAA/S (observer's assessment of alertness/sedation) score
Time Frame: 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 Outcomes
- The amount of rescue analgesics (fentanyl in mg) and rescue hypnotic (propofol in mg)(1 day)