SNAP VS BIS(OAA/S) Scale During a Sedation Regimen With and Without Ketamine

August 18, 2014 updated by: Gildasio De Oliveira, Northwestern University

A Comparison Between the Correlation of the Bispectral Index Versus Snap Index With the Observer's Assessment of Alertness and Sedation (OAA/S) Scale During a Sedation Regimen With and Without Ketamine

The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS Monitor during sedation with ketamine?

The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the use of ketamine.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age : 18-64 years
  • ASA : I-III
  • Procedure : Breast or gynecological surgery
  • Anesthesia :Monitored anesthesia care

Exclusion Criteria:

  • Pregnancy
  • Breast Feeding
  • Body Mass Index >35kg/m2
  • Drug or Alcohol abuse
  • Use anticonvulsants
  • History of CVA

  • Drop-out criteria:

    • Patient or surgeon request
    • Conversion to general anesthesia
    • Inability to obtain data from both monitors

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ketamine Group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Drug: Ketamine group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
No Intervention: No ketamine
No ketamine added to anesthesia regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TcCO2 Above 50
Time Frame: Intraoperative, an average of about 1 and 1/2 hours.
% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
Intraoperative, an average of about 1 and 1/2 hours.

Collaborators and Investigators

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

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Gildasio DeOliveira, MD, Northwestern University

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

August 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00031783

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.

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