Trial Outcomes & Findings for Anesthetic Techniques in EP Patients (NCT NCT02664922)

NCT ID: NCT02664922

Last Updated: 2020-09-22

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

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

Results posted on

2020-09-22

Participant Flow

Participant milestones

Participant milestones
Measure
Sedation - Group 1
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Overall Study
STARTED
11
12
7
5
Overall Study
COMPLETED
10
12
7
5
Overall Study
NOT COMPLETED
1
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anesthetic Techniques in EP Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sedation - Group 1
n=10 Participants
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 Participants
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 Participants
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 Participants
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Total
n=34 Participants
Total of all reporting groups
Age, Continuous
56 years
STANDARD_DEVIATION 16 • n=5 Participants
56 years
STANDARD_DEVIATION 13 • n=7 Participants
48 years
STANDARD_DEVIATION 18 • n=5 Participants
43 years
STANDARD_DEVIATION 16 • n=4 Participants
53 years
STANDARD_DEVIATION 16 • n=21 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
13 Participants
n=21 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
8 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
21 Participants
n=21 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure
Sedation - Group 1
n=10 Participants
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 Participants
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 Participants
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 Participants
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.
1 Participants
2 Participants
0 Participants
0 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure
Sedation - Group 1
n=10 Participants
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 Participants
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 Participants
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 Participants
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Effectiveness of Anesthetic Drugs in Terms of Pain Relief.
1.7 score on a scale
Standard Deviation 1.3
0.4 score on a scale
Standard Deviation 0.5
0.2 score on a scale
Standard Deviation 0.5
0 score on a scale
Standard Deviation 0

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Sedation - Group 1
n=10 Participants
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 Participants
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 Participants
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 Participants
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.
2.9 score on a scale
Standard Deviation 1.2
3.0 score on a scale
Standard Deviation 1.3
3.0 score on a scale
Standard Deviation 1.3
1.0 score on a scale
Standard Deviation 0.0

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Sedation - Group 1
n=10 Participants
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 Participants
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 Participants
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 Participants
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.
3.4 score on a scale
Standard Deviation 0.4
3.0 score on a scale
Standard Deviation 0.7
3.5 score on a scale
Standard Deviation 0.5
3.1 score on a scale
Standard Deviation 0.1

SECONDARY outcome

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

The proceduralist will complete a written questionnaire after the procedure to rate their satisfaction. A Likert Scale is used and ranges from 1 - Disagree very much to 6 - Agree very much.

Outcome measures

Outcome measures
Measure
Sedation - Group 1
n=10 Participants
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 Participants
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 Participants
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 Participants
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.
5.7 score on a scale
Standard Deviation 0.4
5.6 score on a scale
Standard Deviation 0.5
5.2 score on a scale
Standard Deviation 0.3
5.1 score on a scale
Standard Deviation 1.9

SECONDARY outcome

Timeframe: 1-3 months postoperatively

Population: Patients were excluded from analysis if there was no electrophysiology follow-up in the medical record 1-3 months postoperatively.

The proceduralist will follow-up 1-3 months post-procedure to evaluate the number of participants with clinical success reported by number of recurrences. Clinical success is defined as 0 recurrences in participants at 1-3 months post-operatively.

Outcome measures

Outcome measures
Measure
Sedation - Group 1
n=3 Participants
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=5 Participants
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=3 Participants
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=4 Participants
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success.
0 Participants
0 Participants
1 Participants
1 Participants

Adverse Events

Sedation - Group 1

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Sedation - Group 2

Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths

Sedation - Group 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

General Anesthesia - Group 1

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Sedation - Group 1
n=10 participants at risk
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 participants at risk
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 participants at risk
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 participants at risk
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Cardiac disorders
New onset atrial fibrillation requiring cardioversion
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
8.3%
1/12 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/5 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Cardiac disorders
Cardiac Arrest
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/12 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
20.0%
1/5 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Cardiac disorders
VA ECMO
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/12 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
20.0%
1/5 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Cardiac disorders
Multiorgan Failure
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/12 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
20.0%
1/5 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Cardiac disorders
Death
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/12 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
20.0%
1/5 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Blood and lymphatic system disorders
Hyperkalemia
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
8.3%
1/12 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/5 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Renal and urinary disorders
acute kidney injury
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
8.3%
1/12 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/5 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.

Other adverse events

Other adverse events
Measure
Sedation - Group 1
n=10 participants at risk
Sedation - monitored anesthesia with propofol. Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 2
n=12 participants at risk
Sedation - monitored anesthesia with ketamine + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
Sedation - Group 3
n=7 participants at risk
Sedation - monitored anesthesia with remifentanil + propofol Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
General Anesthesia - Group 1
n=5 participants at risk
General anesthesia (GA) with Sevoflurane + O2 Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Cardiac disorders
slow ventricular tachycardia
10.0%
1/10 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/12 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/5 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Cardiac disorders
non-sustained ventricular tachycardia
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
8.3%
1/12 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/5 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
Cardiac disorders
Pericardial Drain
0.00%
0/10 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
8.3%
1/12 • Number of events 1 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/7 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.
0.00%
0/5 • Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours, and up to 5 days.

Additional Information

Jennifer Scovotti

University of California, Los Angeles

Phone: 310.206.4484

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place