TachyarrhythmiaNCT03451227
Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures
A study testing Dexmedetomidine group and Remifentanil Group in people with Tachyarrhythmia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
To evaluate the safety and efficacy of dexmedetomidine and compare this to a current technique commonly used at TGH for sedation in patients undergoing ablation procedures for atrial fibrillation (AF) and atrial flutter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmia
- What is being tested?
- Dexmedetomidine group and Remifentanil Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2017to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 listed for an ablation procedure for treatment of atrial fibrillation or flutter at TGH requiring sedation provided by an anesthetist
- Valid consent
Who cannot join
- Baseline HR <40
- Baseline SBP < 80mmHg
- Baseline SBP > 180mmHg
- Second or third degree heart block unless pacemaker in situ
- Uncontrolled heart failure/severe LV dysfunction (Ejection fraction < 40%)
- Severe hepatic dysfunction (Transaminases greater than 2 times the upper limit of normal)
Show all 13Show fewer
- Renal dysfunction: estimated GFR < 30ml/min, or requiring dialysis
- Allergy to any of the study drugs (dexmedetomidine, remifentanil, fentanyl, midazolam)
- Cognitive impairment precluding ability to tolerate sedation and comply with assessment methods
- Requirement for general anaesthetic for the procedure
- Pregnancy or breast feeding mothers
- Chronic use or addiction to opioids
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, Univerity health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: A Pilot Study to Investigate the Efficacy and Safety of Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures for Treatment of a Tachyarrhythmia
To evaluate the safety and efficacy of dexmedetomidine and compare this to a current technique commonly used at TGH for sedation in patients undergoing ablation procedures for atrial fibrillation (AF) and atrial flutter.
The investigators hypothesise that dexmedetomidine will be at least equivalent to, or more so, in terms of effectiveness and safety, when compared to midazolam and remifentanil for sedation during ablation procedures.
Read the detailed description
The role of ablation for chronic persistent AF has been debated amongst cardiologists for some time, and there is increasing evidence that ablation may be superior to medical management. As populations age, the rate of AF is likely to increase and therefore the numbers of ablations performed for this arrhythmia will also be expected to increase.
Ablation procedures can vary in length from one to more than 6 hours in duration and require the patient to keep still so as not to influence the mapping procedure.
Options for anaesthesia care include a general anaesthetic or sedation. Several studies have evaluated the safety of sedation for ablation, using combinations of fentanyl, midazolam and propofol. These demonstrate that the ablation procedures are well tolerated under deep sedation.
Dexmedetomidine is an attractive potential agent for this role due to its favourable respiratory pharmacodynamics and good sedation profile. Dexmedetomidine is a short acting relatively specific alpha-2 receptor agonist (alpha 2: alpha 1 = 1300:1). It has been shown to have very little effect on respiratory parameters, even at high doses.In addition, it may offer some analgesic properties and therefore minimise the need for narcotic based agents. the investigators will compare dexmedetomidine infusion and fentanyl bolus with remifentanil infusion midazolam bolus.
- Conditions
- Tachyarrhythmia
- Being tested
- Dexmedetomidine group, Remifentanil Group
- Keywords
- Sedation, Analgesia
- Medical subject headings
- Tachycardia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine groupDrug
The study drug dexmedetomidine (PrecedexTM) will be infused at 0.2-1mcg/kg/hour from the start of the case. The dexmedetomidine infusion will stop at completion of the procedure.
Remifentanil GroupDrug
Remifentanil HCL will be infused at 0.01-0.2 mcg/kg/min titrated to sedation level (SAS less than or equal to 4) and cardiovascular parameters (within 30% of baseline). The infusion will be stopped at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | The study drug dexmedetomidine (PrecedexTM) is supplied as dexmedetomidine HCL 200mcg/vial (100mcg/ml). This will be added to 98 ml 0.9% NaCl to achieve a concentration of 2mcg/ml and infused at 0.2-1mcg/kg/hour from the start of the case. The infusion rate will be commenced at 1mcg/kg/hour in those less than or equal to 65 years of age, and at 0.7mcg/kg/hr in those greater than 65 years of age, and then titrated based on the intraoperative sedation scores (to achieve a Sedation and Agitation scale (SAS) score of less than or equal to 4) and cardiovascular parameters (within 30% of baseline). Receives: Drug: Dexmedetomidine group |
| Remifentanil Group | Active comparator | Remifentanil HCL will be infused at 0.01-0.2 mcg/kg/min titrated to sedation level (SAS less than or equal to 4) and cardiovascular parameters (within 30% of baseline) Receives: Drug: Remifentanil Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of haemodynamic events requiring intervention
a.Hypotension i. A decrease of 30% or more from baseline ii. Or absolute cut off values of
- SBP < 80mmHg
- DBP <40mmHg iii. Number of events and total dose of phenylephrine or ephedrine administered.
- Hypertension i. An increase in Systolic blood pressure 30% or more from baseline ii. Or an absolute cut off value of > 180mmHg iii. Total number of events c. Bradycardia i. A decrease of 30% or more from baseline ii. Or absolute cut off values of < 40bpm iii. Total number of events and total dose of glycopyrolate or atropine administered.
Measured: up to 24 hours
Number of respiratory events requiring intervention
Respiratory events requiring intervention
- Respiratory rate < 6 breaths/min
- Airway obstruction requiring manual support
- Airway obstruction requiring guedel insertion
- Apnoea (cessation of respiration >10seconds)
- Hypoxia (saturations <90% for >20 seconds)
Measured: up to 24 hours
Secondary outcomes (8)
Intraoperative pain scores
- VAS score (visual analog score). VAS is a simple assessment tool consisting of a 10 cm line with 0 on one end, representing no pain, and 10 on the other, representing the worst pain ever experienced, which a patient indicates so the clinician knows the severity of his or her pain. Pain scores using a VAS scale ranging from zero to ten will be recorded every 30 minutes
- Total amount of additional fentanyl used intraoperatively
Measured: up to 24 hours
Intraoperative sedation scores
- Sedation Agitation Scale (SAS) scale range from 1 to 7 will be recorded every 5 minutes. The SAS scale is outlined below with an optimal score of 4 for procedural sedation. Ref: Riker RR, Picard JT and Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Critical Care Medicine 1999;27(7):1325-1329.
- Total amount of additional midazolam used intraoperatively
Measured: up to 24 hours
Patient satisfaction
Assessed with the Iowa Satisfaction with Anaesthesia scale 24 hours post procedure b. Assessor blinded to technique c. To include direct questioning regarding the patients willingness to undergo the same procedure again using the same technique
Iowa Satisfaction with Anaesthesia scale
Ref: Dexter F, Aker J, Wright W. Development of a measure of patient satisfaction with monitored anaesthetic care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology 1997; 87: 865-73.
Patient assessment
- I threw up or felt like throwing up
- I would have the same anaesthetic again
- I itched
- I felt relaxed
- I felt pain
- I felt safe
- I was too hot or cold
- I was satisfied with the anesthesia care
- I felt pain during the surgery
- I felt good
- I hurt
Measured: up to 48 hours
Recovery time
Time from stopping infusion to a SAS score of ≥4
Measured: up to 24 hours
Length of stay in the recovery unit
Total time spent in recovery until appropriate discharge criteria are met and patient is discharged to the ward
Measured: up to 24 hours
Analgesia requirements
Quantity of opioids required i. Intraoperatively ii. In recovery iii. In the first 24 hours post op
Measured: up to 24 hours
Post operative nausea and vomiting (PONV)
- Subjective or objective evidence of PONV lasting > 30 mins
- Antiemetic therapy administered
Measured: up to 24 hours
Itch
Any complaints of itch during the procedure and 24 hours post operatively
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Dec 2017
- Primary completion12 Mar 2018
- Study completion14 May 2019
Why it stopped: Unable to recruit eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for TachyarrhythmiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single blind, randomised controlled study looking at the feasibility of dexmedetomidine for sedation during ablation procedures at Toronto General Hospital.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Carroll, University Health Network, Toronto
- Investigators
- George Djaiani, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451227
- Sponsor's protocol ID
- 13-6972-B
- Status last verified
- May 2019
- First submitted
- 30 Nov 2017
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verma A, Natale A. Should atrial fibrillation ablation be considered first-line therapy for some patients? Why atrial fibrillation ablation should be considered first-line therapy for some patients. Circulation. 2005 Aug 23;112(8):1214-22; discussion 1231. doi: 10.1161/CIRCULATIONAHA.104.478263. No abstract available.
PubMed 16116072Di Biase L, Santangeli P, Natale A. How to ablate long-standing persistent atrial fibrillation? Curr Opin Cardiol. 2013 Jan;28(1):26-35. doi: 10.1097/HCO.0b013e32835b59bb.
PubMed 23207492Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.
PubMed 19995881Drabek T, Nemec J. Anesthetic management of electrophysiological procedures for heart failure. Int Anesthesiol Clin. 2012 Summer;50(3):22-42. doi: 10.1097/AIA.0b013e3182603e95.
PubMed 22735718Di Biase L, Conti S, Mohanty P, Bai R, Sanchez J, Walton D, John A, Santangeli P, Elayi CS, Beheiry S, Gallinghouse GJ, Mohanty S, Horton R, Bailey S, Burkhardt JD, Natale A. General anesthesia reduces the prevalence of pulmonary vein reconnection during repeat ablation when compared with conscious sedation: results from a randomized study. Heart Rhythm. 2011 Mar;8(3):368-72. doi: 10.1016/j.hrthm.2010.10.043. Epub 2010 Nov 2.
PubMed 21055479Di Biase L, Saenz LC, Burkhardt DJ, Vacca M, Elayi CS, Barrett CD, Horton R, Bai R, Siu A, Fahmy TS, Patel D, Armaganijan L, Wu CT, Kai S, Ching CK, Phillips K, Schweikert RA, Cummings JE, Arruda M, Saliba WI, Dodig M, Natale A. Esophageal capsule endoscopy after radiofrequency catheter ablation for atrial fibrillation: documented higher risk of luminal esophageal damage with general anesthesia as compared with conscious sedation. Circ Arrhythm Electrophysiol. 2009 Apr;2(2):108-12. doi: 10.1161/CIRCEP.108.815266. Epub 2009 Feb 13.
PubMed 19808454Wutzler A, Rolf S, Huemer M, Parwani AS, Boldt LH, Herberger E, Hohenbichler K, Dietz R, Haverkamp W. Safety aspects of deep sedation during catheter ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2012 Jan;35(1):38-43. doi: 10.1111/j.1540-8159.2011.03260.x. Epub 2011 Nov 6.
PubMed 22054234Kottkamp H, Hindricks G, Eitel C, Muller K, Siedziako A, Koch J, Anastasiou-Nana M, Varounis C, Arya A, Sommer P, Gaspar T, Piorkowski C, Dagres N. Deep sedation for catheter ablation of atrial fibrillation: a prospective study in 650 consecutive patients. J Cardiovasc Electrophysiol. 2011 Dec;22(12):1339-43. doi: 10.1111/j.1540-8167.2011.02120.x. Epub 2011 Jun 21.
PubMed 21692895Salukhe TV, Willems S, Drewitz I, Steven D, Hoffmann BA, Heitmann K, Rostock T. Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation. Europace. 2012 Mar;14(3):325-30. doi: 10.1093/europace/eur328. Epub 2011 Oct 23.
PubMed 22024600Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.
PubMed 16436839Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
PubMed 19713256Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. doi: 10.1046/j.1365-2044.1999.00659.x.
PubMed 10215710Belleville JP, Ward DS, Bloor BC, Maze M. Effects of intravenous dexmedetomidine in humans. I. Sedation, ventilation, and metabolic rate. Anesthesiology. 1992 Dec;77(6):1125-33. doi: 10.1097/00000542-199212000-00013.
PubMed 1361310Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
PubMed 10702460Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. doi: 10.1097/00000542-200008000-00016.
PubMed 10910487
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Efficacy and Safety of Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures for Treatment of a Tachyarrhythmia
- ClinicalTrials.gov ID
- NCT03451227
- Acronym / sponsor ID
- 13-6972-B
- Conditions
- Tachyarrhythmia
- Keywords
- Sedation, Analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit eligible participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of dexmedetomidine and compare this to a current technique commonly used at TGH for sedation in patients undergoing ablation procedures for atrial fibrillation (AF) and atrial flutter.
The investigators hypothesise that dexmedetomidine will be at least equivalent to, or more so, in terms of effectiveness and safety, when compared to midazolam and remifentanil for sedation during ablation procedures.
Detailed description
The role of ablation for chronic persistent AF has been debated amongst cardiologists for some time, and there is increasing evidence that ablation may be superior to medical management. As populations age, the rate of AF is likely to increase and therefore the numbers of ablations performed for this arrhythmia will also be expected to increase.
Ablation procedures can vary in length from one to more than 6 hours in duration and require the patient to keep still so as not to influence the mapping procedure.
Options for anaesthesia care include a general anaesthetic or sedation. Several studies have evaluated the safety of sedation for ablation, using combinations of fentanyl, midazolam and propofol. These demonstrate that the ablation procedures are well tolerated under deep sedation.
Dexmedetomidine is an attractive potential agent for this role due to its favourable respiratory pharmacodynamics and good sedation profile. Dexmedetomidine is a short acting relatively specific alpha-2 receptor agonist (alpha 2: alpha 1 = 1300:1). It has been shown to have very little effect on respiratory parameters, even at high doses.In addition, it may offer some analgesic properties and therefore minimise the need for narcotic based agents. the investigators will compare dexmedetomidine infusion and fentanyl bolus with remifentanil infusion midazolam bolus.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This is a prospective, single blind, randomised controlled study looking at the feasibility of dexmedetomidine for sedation during ablation procedures at Toronto General Hospital.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine groupThe study drug dexmedetomidine (PrecedexTM) is supplied as dexmedetomidine HCL 200mcg/vial (100mcg/ml). This will be added to 98 ml 0.9% NaCl to achieve a concentration of 2mcg/ml and infused at 0.2-1mcg/kg/hour from the start of the case. The infusion rate will be commenced at 1mcg/kg/hour in those less than or equal to 65 years of age, and at 0.7mcg/kg/hr in those greater than 65 years of age, and then titrated based on the intraoperative sedation scores (to achieve a Sedation and Agitation scale (SAS) score of less than or equal to 4) and cardiovascular parameters (within 30% of baseline). |
| Remifentanil Group | Active comparator | Drug: Remifentanil GroupRemifentanil HCL will be infused at 0.01-0.2 mcg/kg/min titrated to sedation level (SAS less than or equal to 4) and cardiovascular parameters (within 30% of baseline) |
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 listed for an ablation procedure for treatment of atrial fibrillation or flutter at TGH requiring sedation provided by an anesthetist
- Valid consent
Key exclusion criteria (13 listed)
- Baseline HR <40
- Baseline SBP < 80mmHg
- Baseline SBP > 180mmHg
- Second or third degree heart block unless pacemaker in situ
- Uncontrolled heart failure/severe LV dysfunction (Ejection fraction < 40%)
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 |
|---|---|---|
| Dexmedetomidine groupThe study drug dexmedetomidine (PrecedexTM) will be infused at 0.2-1mcg/kg/hour from the start of the case. The dexmedetomidine infusion will stop at completion of the procedure. | Drug | Dexmedetomidine Group |
| Remifentanil GroupRemifentanil HCL will be infused at 0.01-0.2 mcg/kg/min titrated to sedation level (SAS less than or equal to 4) and cardiovascular parameters (within 30% of baseline). The infusion will be stopped at the end of the procedure. | Drug | Remifentanil Group |
Primary outcome
Number of haemodynamic events requiring intervention
Time frame: up to 24 hours
a.Hypotension i. A decrease of 30% or more from baseline ii. Or absolute cut off values of 1. SBP < 80mmHg 2. DBP <40mmHg iii. Number of events and total dose of phenylephrine or ephedrine administered. b. Hypertension i. An increase in Systolic blood pressure 30% or more from baseline ii. Or an absolute cut off value of > 180mmHg iii. Total number of events c. Bradycardia i. A decrease of 30% or more from baseline ii. Or absolute cut off values of < 40bpm iii. Total number of events and total dose of glycopyrolate or atropine administered.
Number of respiratory events requiring intervention
Time frame: up to 24 hours
Respiratory events requiring intervention 1. Respiratory rate < 6 breaths/min 2. Airway obstruction requiring manual support 3. Airway obstruction requiring guedel insertion 4. Apnoea (cessation of respiration >10seconds) 5. Hypoxia (saturations <90% for >20 seconds)
8 secondary outcomes
Intraoperative pain scores
Time frame: up to 24 hours
Intraoperative sedation scores
Time frame: up to 24 hours
Patient satisfaction
Time frame: up to 48 hours
Recovery time
Time frame: up to 24 hours
Length of stay in the recovery unit
Time frame: up to 24 hours
Analgesia requirements
Time frame: up to 24 hours
Post operative nausea and vomiting (PONV)
Time frame: up to 24 hours
Itch
Time frame: up to 24 hours
Results and safety
The study was stopped early (reason given: Unable to recruit eligible participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Background: PubMed 16116072Verma A, Natale A. Should atrial fibrillation ablation be considered first-line therapy for some patients? Why atrial fibrillation ablation should be considered first-line therapy for some patients. Circulation. 2005 Aug 23;112(8):1214-22; discussion 1231. doi: 10.1161/CIRCULATIONAHA.104.478263. No abstract available.
- Background: PubMed 23207492Di Biase L, Santangeli P, Natale A. How to ablate long-standing persistent atrial fibrillation? Curr Opin Cardiol. 2013 Jan;28(1):26-35. doi: 10.1097/HCO.0b013e32835b59bb.
- Background: PubMed 19995881Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.
- Background: PubMed 22735718Drabek T, Nemec J. Anesthetic management of electrophysiological procedures for heart failure. Int Anesthesiol Clin. 2012 Summer;50(3):22-42. doi: 10.1097/AIA.0b013e3182603e95.
- Background: PubMed 21055479Di Biase L, Conti S, Mohanty P, Bai R, Sanchez J, Walton D, John A, Santangeli P, Elayi CS, Beheiry S, Gallinghouse GJ, Mohanty S, Horton R, Bailey S, Burkhardt JD, Natale A. General anesthesia reduces the prevalence of pulmonary vein reconnection during repeat ablation when compared with conscious sedation: results from a randomized study. Heart Rhythm. 2011 Mar;8(3):368-72. doi: 10.1016/j.hrthm.2010.10.043. Epub 2010 Nov 2.
- Background: PubMed 19808454Di Biase L, Saenz LC, Burkhardt DJ, Vacca M, Elayi CS, Barrett CD, Horton R, Bai R, Siu A, Fahmy TS, Patel D, Armaganijan L, Wu CT, Kai S, Ching CK, Phillips K, Schweikert RA, Cummings JE, Arruda M, Saliba WI, Dodig M, Natale A. Esophageal capsule endoscopy after radiofrequency catheter ablation for atrial fibrillation: documented higher risk of luminal esophageal damage with general anesthesia as compared with conscious sedation. Circ Arrhythm Electrophysiol. 2009 Apr;2(2):108-12. doi: 10.1161/CIRCEP.108.815266. Epub 2009 Feb 13.
- Background: PubMed 22054234Wutzler A, Rolf S, Huemer M, Parwani AS, Boldt LH, Herberger E, Hohenbichler K, Dietz R, Haverkamp W. Safety aspects of deep sedation during catheter ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2012 Jan;35(1):38-43. doi: 10.1111/j.1540-8159.2011.03260.x. Epub 2011 Nov 6.
- Background: PubMed 21692895Kottkamp H, Hindricks G, Eitel C, Muller K, Siedziako A, Koch J, Anastasiou-Nana M, Varounis C, Arya A, Sommer P, Gaspar T, Piorkowski C, Dagres N. Deep sedation for catheter ablation of atrial fibrillation: a prospective study in 650 consecutive patients. J Cardiovasc Electrophysiol. 2011 Dec;22(12):1339-43. doi: 10.1111/j.1540-8167.2011.02120.x. Epub 2011 Jun 21.
- Background: PubMed 22024600Salukhe TV, Willems S, Drewitz I, Steven D, Hoffmann BA, Heitmann K, Rostock T. Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation. Europace. 2012 Mar;14(3):325-30. doi: 10.1093/europace/eur328. Epub 2011 Oct 23.
- Background: PubMed 16436839Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.
- Background: PubMed 19713256Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
- Background: PubMed 10215710Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. doi: 10.1046/j.1365-2044.1999.00659.x.
- 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.
George Djaiani, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine group and Remifentanil Group in people with Tachyarrhythmia, run by University Health Network, Toronto at 1 site in Canada.
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 13 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 16 May 2019. 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 Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit eligible participants). Results are not available in the source record.
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?
Number of haemodynamic events requiring intervention (time frame: up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451227, which also lists 38 linked publications.
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 16 May 2019.