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

Sedation Clinical Trial

— BIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399019
• Other study ID #: 2016-I097
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2017
• Last updated: January 7, 2018
• Start date: September 5, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: January 2018
• Source: Hallym University Medical Center
• Contact: Yi Hwa Choi, M.D
• Phone: +82-31-380-3945
• Email: pcyhchoi[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 31, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Sedation

Intervention

Drug:
• Dexmedetomidine
initial loading dose (0.5 ~ 1?/kg for 10 minutes) and maintenance infusion (0.2-0.7?/kg/hr)
• Propofol
continuous infusion (0.75-3mg/kg/hr)
• 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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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