N/A
Completed N=20
Measurement of Bispectral Index and Awareness in Patients Undergoing Electrophysiology Studies With Isoproterenol
Intraoperative Awareness
Source: ClinicalTrials.gov NCT01377636 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Number of Participants With an Increase in BIS Readings During Steady State — 19 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Increase in BIS Readings During Steady State |
19 | — |
| PRIMARY BIS Change |
24.6 | — |
| SECONDARY Number of Participants With Spontaneous Musculoskeletal Movement |
12 | — |
| SECONDARY Number of Participants Who Follow Verbal Command to Squeeze Hands |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for EP studies for catheter ablation of atrial fibrillation under general anesthesia will participate in the study
Exclusion Criteria
- Patients with neuromuscular disease precluding the use of succinylcholine will be excluded.
- Patient or cardiologist refusal
Data sourced from ClinicalTrials.gov (NCT01377636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.