Anesthetic Techniques in EP Patients

NCT02664922 | Terminated Phase 4 Results DMC

• 1 other identifier: Anes Tech 11-003514
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare different combinations of anesthetic drugs (cause loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient comfort for cardiac electrophysiology procedures. In addition, the investigators are studying the different anesthetic combinations to determine the best approach in terms of identification and treatment of arrhythmias.

Conditions

Cardiac Disease

Keywords

Electrophysiology; Anesthetics

Outcome Measures

Primary Outcomes (4)

• Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.

  Direct observation and medical record review will be used to analyze adverse effects. Reported as number of participants with one or more adverse events.

  Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.

• Effectiveness of Anesthetic Drugs in Terms of Pain Relief.

  A patient's pain level will be assessed using a numerical pain rating scale from 0 "no pain" to 10 "worst possible pain".

  Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.

• Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.

  A patient's level of sedation will be assessed using a scoring system on a scale from 1-5. The Observer's Assessment of Alertness/Sedation (OAA/S) Score Responsiveness Component score from 1 - Does not respond to mild prodding or shaking to 5 - Responds readily to name spoken in normal tone.

  Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.

• Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.

  Patients will also be asked to complete a written questionnaire prior to discharge from the hospital to measure patient satisfaction during their anesthesia care. A Likert Scale is used and ranges from 1 - Disagree very much to 6 - Agree very much.

  Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.

Secondary Outcomes (2)

• Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.

  Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.

• Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success.

  1-3 months postoperatively

Study Arms (4)

Sedation - Group 1

EXPERIMENTAL

Sedation - monitored anesthesia with propofol.

Drug: Propofol

Sedation - Group 2

EXPERIMENTAL

Sedation - monitored anesthesia with ketamine + propofol

Drug: Propofol; Drug: Ketamine

Sedation - Group 3

EXPERIMENTAL

Sedation - monitored anesthesia with remifentanil + propofol

Drug: Propofol; Drug: Remifentanil

General Anesthesia - Group 1

EXPERIMENTAL

General anesthesia (GA) with Sevoflurane + O2

Drug: Sevoflurane

Interventions

Propofol DRUG

1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.

Also known as: Diprivan

Sedation - Group 1; Sedation - Group 2; Sedation - Group 3

Ketamine DRUG

1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.

Also known as: Ketalar

Sedation - Group 2

Remifentanil DRUG

1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.

Also known as: Ultiva

Sedation - Group 3

Sevoflurane DRUG

1 general anesthesia group for VT ablations and afib procedures.

Also known as: Ultane

General Anesthesia - Group 1

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 cardiac electrophysiology procedures
• Patients ≥18 years of age

You may not qualify if:

• Gastroesophageal reflux disease (GERD),
• pulmonary hypertension,
• severe pulmonary disease,
• obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Propofol; Ketamine; Remifentanil; Sevoflurane

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Jennifer Scovotti
• Organization: University of California, Los Angeles

jscovotti@mednet.ucla.edu

310.206.4484

Study Officials

• Aman Mahajan, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: January 27, 2016
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 22, 2020
• Results First Posted: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)