Measurement of Bispectral Index and Awareness in Patients Undergoing Electrophysiology Studies With Isoproterenol

NCT01377636 | Completed Results

• 1 other identifier: H#: 09-0440
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Isoproterenol is used as a cardiac stimulant in electrophysiology studies (EP). Preliminary data suggests that administration of isoproterenol increases the Bispectral index (BIS). BIS is used to monitor neuronal signals under anesthesia. The BIS level is suggested to correspond to the level of consciousness. We hypothesize that isoproterenol increases BIS values because it increases the patient's level of consciousness through its central nervous system (CNS) stimulatory effects. In this study, we will administer increasing doses of isoproterenol to EPS patients. We will measure the BIS levels continuously before and after isoproterenol administration. In addition, we will test the level of awareness of patients by their response to a modified isolated forearm technique.

Conditions

Intraoperative Awareness

Keywords

Isoproterenol; Bispectral index (BIS); electrophysiology studies (EPS)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With an Increase in BIS Readings During Steady State

  Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. BIS levels were measured continuously before and after isoproterenol administration. Number of participants with increase in BIS reading during anesthetic steady state are reported below. The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.

  During time of Electrophysiology (EP) studies.

• BIS Change

  The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.The difference between Pre-BIS and Post-BIS was calculated.

  Within 20 minutes of starting isoproterenol infusion

Secondary Outcomes (2)

• Number of Participants With Spontaneous Musculoskeletal Movement

  Within 20 minutes of starting isoproterenol infusion

• Number of Participants Who Follow Verbal Command to Squeeze Hands

  Within 20 minutes of starting isoproterenol infusion

Other Outcomes (5)

• Number of Participants With Significant Change in Heart Rate

  Within 20 minutes of starting isoproterenol infusion

• Number of Participants With Change in Blood Pressure

  Within 20 minutes of starting isoproterenol infusion

• Number of Participants With Amnesia or No Recall During Steady State

  Within one hour of completing anesthesia

Study Arms (1)

Isoproterenol, BIS, forearm test

EXPERIMENTAL

30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.

Drug: Isoproterenol

Interventions

Isoproterenol DRUG

patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade).

Also known as: isoprenaline

Isoproterenol, BIS, forearm test

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for EP studies for catheter ablation of atrial fibrillation under general anesthesia will participate in the study

You may not qualify if:

• Patients with neuromuscular disease precluding the use of succinylcholine will be excluded.
• Patient or cardiologist refusal

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center, Department of Anesthesiology

New York, New York, 10016, United States

Location

Related Publications (1)

• O'Neill DK, Aizer A, Linton P, Bloom M, Rose E, Chinitz L. Isoproterenol infusion increases level of consciousness during catheter ablation of atrial fibrillation. J Interv Card Electrophysiol. 2012 Aug;34(2):137-42. doi: 10.1007/s10840-011-9652-3. Epub 2012 Feb 25.

  PMID: 22366997 BACKGROUND

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Isoproterenol

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Patrick Linton, MD, Director of Adult Off-Site Anesthesia Services
• Organization: New York University Langone Medical Center, Anesthesiology

Patrick.Linton@nyumc.org

212-263-5072

Study Officials

• Patrick Linton, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: June 21, 2011
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

US (1)