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

NCT03399019 | Unknown DMC

• 1 other identifier: 2016-I097
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Anesthesia, Spinal

Keywords

Bispectral index monitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The amount of rescue analgesics (fentanyl in mg) and rescue hypnotic (propofol in mg)

  1 day

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

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

Propofol

ACTIVE COMPARATOR

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

Midazolam

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine

Propofol DRUG

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

Propofol

Midazolam 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

Midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who scheduled for knee arthroscopic surgery under spinal anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, KS009, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 22828857 BACKGROUND

• 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.

  PMID: 11878517 BACKGROUND

• 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.

  PMID: 19923507 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Propofol; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Soo Kyung Lee, M.D

  Hallym University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Yi Hwa Choi, M.D

CONTACT

+82-31-380-3945; pcyhchoi@hallym.or.kr

Soo Kyung Lee, M.D

CONTACT

+82-31-380-3945; agneta@hallym.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 16, 2018
• Study Start: September 5, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 31, 2018
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

KR (1)