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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sedation; Anesthesia, Spinal
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol; Drug: Midazolam

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Hwa Choi, M.D; Phone Number: +82-31-380-3945; Email: pcyhchoi@hallym.or.kr
• Study Contact Backup: Name: Soo Kyung Lee, M.D; Phone Number: +82-31-380-3945; Email: agneta@hallym.or.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, Korea, Republic of, KS009
      • Recruiting
      • Hallym University Sacred Heart Hospital
      • Contact: Soo Kyung Lee, MD; Phone Number: 3944 +82-31-380-3944; Email: agnetask@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Dexmedetomidine; initial loading dose (0.5 ~ 1㎍/kg for 10 minutes) and maintenance infusion (0.2-0.7㎍/kg/hr)
Active Comparator: 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	Drug: Propofol; continuous infusion (0.75-3mg/kg/hr)
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between BIS and OAA/S (observer's assessment of alertness/sedation) score	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of rescue analgesics (fentanyl in mg) and rescue hypnotic (propofol in mg)	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	1 day

Collaborators and Investigators

• Sponsor: Hallym University Medical Center
• Investigators: Study Director: Soo Kyung Lee, M.D, Hallym University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 31, 2018

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 7, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Bispectral index monitor
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Propofol; Dexmedetomidine
• Other Study ID Numbers: 2016-I097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided