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

NCT03399019 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-01-16

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

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

DRUG

Propofol

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

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

Sponsors & Collaborators

  • Hallym University Medical Center

    lead OTHER

Principal Investigators

  • Soo Kyung Lee, M.D · Hallym University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2018-03-01
Completion
2018-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03399019 on ClinicalTrials.gov