Cardiac DiseasePhase 4NCT02664922
Anesthetic Techniques in EP Patients
A Phase 4 study testing Propofol, Ketamine and Remifentanil in people with Cardiac Disease, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Propofol, Ketamine and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for cardiac electrophysiology procedures
- Patients ≥18 years of age
Who cannot join
- Gastroesophageal reflux disease (GERD),
- pulmonary hypertension,
- severe pulmonary disease,
- obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
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.
Read the detailed description
Anesthetic management in patients coming for electrophysiology procedures is extremely important and hemodynamically challenging in order to minimize interference on the electrophysiology studies (EPS) and the ability to trigger arrhythmias while also maintaining patient comfort and limited movement. Various anesthetic combinations are administered to provide sedation, analgesia/sedation, or general anesthesia. The ideal agent should produce rapid loss of consciousness while ensuring cardiovascular stability and prompt recovery with few adverse effects. Our goal is to study anesthetic techniques and the effect on electrophysiology procedures to determine the best anesthetic combination in terms of effectiveness, adverse effects, pain relief, and patient comfort.
Adult patients scheduled for electrophysiology procedures will be enrolled in the study and randomly assigned to an anesthetic group based on their schedule procedure. Sedation cases for supraventricular tachycardia (SVT), right ventricular outflow tract (RVOT)/premature ventricular contraction (PVC) ablation, and atrial flutter (aflutter) procedures will be randomly assigned to one of three groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep), or 3) monitored anesthesia with remifentanil infusion (pain reliever) + propofol (induce sleep). Sedation cases for ventricular tachycardia (VT) ablation and atrial fibrillation (afib) procedures will be randomly assigned to one of two groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), or 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep). General anesthesia (GA) cases, including VT ablation and afib procedures will receive general anesthesia (state of unconsciousness) with sevoflurane (loss of consciousness) + O2. Anesthesia factors, such as hemodynamics and cerebral oxygen saturation will be continuously monitored and recorded throughout the study. In addition, we will be looking at standard echocardiogram and electrophysiology (EP) parameters. The patient's pain level, level of sedation, and satisfaction will also be measured using scales, assessments, and surveys.
- Conditions
- Cardiac Disease
- Being tested
- Propofol, Ketamine, Remifentanil, Sevoflurane
- Keywords
- Electrophysiology, Anesthetics
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.
KetamineDrug
Also called Ketalar
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.
RemifentanilDrug
Also called Ultiva
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
SevofluraneDrug
Also called Ultane
1 general anesthesia group for VT ablations and afib procedures.
| Study group | Role | What they receive |
|---|---|---|
| Sedation - Group 1 | Experimental | Sedation - monitored anesthesia with propofol. Receives: Drug: Propofol |
| Sedation - Group 2 | Experimental | Sedation - monitored anesthesia with ketamine + propofol Receives: Drug: Propofol; Drug: Ketamine |
| Sedation - Group 3 | Experimental | Sedation - monitored anesthesia with remifentanil + propofol Receives: Drug: Propofol; Drug: Remifentanil |
| General Anesthesia - Group 1 | Experimental | General anesthesia (GA) with Sevoflurane + O2 Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 1-3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionDec 2013
Why it stopped: Poor study design and too many study groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aman Mahajan, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664922
- Sponsor's protocol ID
- Anes Tech 11-003514
- Status last verified
- Sep 2020
- First submitted
- 5 Oct 2014
- Last updated
- 22 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
- ClinicalTrials.gov ID
- NCT02664922
- Acronym / sponsor ID
- Anes Tech 11-003514
- Conditions
- Cardiac Disease
- Keywords
- Electrophysiology, Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor study design and too many study groups.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 22 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anesthetic management in patients coming for electrophysiology procedures is extremely important and hemodynamically challenging in order to minimize interference on the electrophysiology studies (EPS) and the ability to trigger arrhythmias while also maintaining patient comfort and limited movement. Various anesthetic combinations are administered to provide sedation, analgesia/sedation, or general anesthesia. The ideal agent should produce rapid loss of consciousness while ensuring cardiovascular stability and prompt recovery with few adverse effects. Our goal is to study anesthetic techniques and the effect on electrophysiology procedures to determine the best anesthetic combination in terms of effectiveness, adverse effects, pain relief, and patient comfort.
Adult patients scheduled for electrophysiology procedures will be enrolled in the study and randomly assigned to an anesthetic group based on their schedule procedure. Sedation cases for supraventricular tachycardia (SVT), right ventricular outflow tract (RVOT)/premature ventricular contraction (PVC) ablation, and atrial flutter (aflutter) procedures will be randomly assigned to one of three groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep), or 3) monitored anesthesia with remifentanil infusion (pain reliever) + propofol (induce sleep). Sedation cases for ventricular tachycardia (VT) ablation and atrial fibrillation (afib) procedures will be randomly assigned to one of two groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), or 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep). General anesthesia (GA) cases, including VT ablation and afib procedures will receive general anesthesia (state of unconsciousness) with sevoflurane (loss of consciousness) + O2. Anesthesia factors, such as hemodynamics and cerebral oxygen saturation will be continuously monitored and recorded throughout the study. In addition, we will be looking at standard echocardiogram and electrophysiology (EP) parameters. The patient's pain level, level of sedation, and satisfaction will also be measured using scales, assessments, and surveys.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sedation - Group 1 | Experimental | Drug: PropofolSedation - monitored anesthesia with propofol. |
| Sedation - Group 2 | Experimental | Drug: Propofol, Drug: KetamineSedation - monitored anesthesia with ketamine + propofol |
| Sedation - Group 3 | Experimental | Drug: Propofol, Drug: RemifentanilSedation - monitored anesthesia with remifentanil + propofol |
| General Anesthesia - Group 1 | Experimental | Drug: SevofluraneGeneral anesthesia (GA) with Sevoflurane + O2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for cardiac electrophysiology procedures
- Patients ≥18 years of age
Key exclusion criteria (4 listed)
- Gastroesophageal reflux disease (GERD),
- pulmonary hypertension,
- severe pulmonary disease,
- obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Diprivan1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. | Drug | Sedation - Group 1, Sedation - Group 2, Sedation - Group 3 |
| KetamineAlso: Ketalar1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures. | Drug | Sedation - Group 2 |
| RemifentanilAlso: Ultiva1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. | Drug | Sedation - Group 3 |
| SevofluraneAlso: Ultane1 general anesthesia group for VT ablations and afib procedures. | Drug | General Anesthesia - Group 1 |
Primary outcome
Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.
Time frame: 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.
Effectiveness of Anesthetic Drugs in Terms of Pain Relief.
Time frame: 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".
Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.
Time frame: 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.
Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.
Time frame: 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.
2 secondary outcomes
Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.
Time frame: 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.
Time frame: 1-3 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aman Mahajan, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Ketamine and Remifentanil in people with Cardiac Disease, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events. (time frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.