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

January 7, 2018 updated by: Hallym University Medical Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, KS009
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
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)
Time Frame: 1 day
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

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-I097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedation

Clinical Trials on Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe