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Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451227
Recruitment Status : Terminated (Unable to recruit eligible participants)
First Posted : March 1, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jo Carroll, University Health Network, Toronto

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Tachyarrhythmia Drug: Dexmedetomidine group Drug: Remifentanil Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Masking Description:

Patients will be randomly allocated (computer generated) to receive either a dexmedetomidine infusion or a remifentanil infusion.

The patient, interventional cardiologist and data analyser will be blinded to the drugs given. The anaesthesia care provider will not be blinded

Primary Purpose: Basic Science
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
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : May 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine Group
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).
Drug: Dexmedetomidine group
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.

Active Comparator: Remifentanil Group
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)
Drug: Remifentanil Group
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.




Primary Outcome Measures :
  1. 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.


  2. 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)


Secondary Outcome Measures :
  1. Intraoperative pain scores [ Time Frame: up to 24 hours ]
    1. 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
    2. Total amount of additional fentanyl used intraoperatively

  2. Intraoperative sedation scores [ Time Frame: up to 24 hours ]
    1. 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.

    2. Total amount of additional midazolam used intraoperatively

  3. Patient satisfaction [ Time Frame: up to 48 hours ]

    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

    1. I threw up or felt like throwing up
    2. I would have the same anaesthetic again
    3. I itched
    4. I felt relaxed
    5. I felt pain
    6. I felt safe
    7. I was too hot or cold
    8. I was satisfied with the anesthesia care
    9. I felt pain during the surgery
    10. I felt good
    11. I hurt

  4. Recovery time [ Time Frame: up to 24 hours ]
    Time from stopping infusion to a SAS score of ≥4

  5. Length of stay in the recovery unit [ Time Frame: up to 24 hours ]
    Total time spent in recovery until appropriate discharge criteria are met and patient is discharged to the ward

  6. Analgesia requirements [ Time Frame: up to 24 hours ]
    Quantity of opioids required i. Intraoperatively ii. In recovery iii. In the first 24 hours post op

  7. Post operative nausea and vomiting (PONV) [ Time Frame: up to 24 hours ]
    1. Subjective or objective evidence of PONV lasting > 30 mins
    2. Antiemetic therapy administered

  8. Itch [ Time Frame: up to 24 hours ]
    Any complaints of itch during the procedure and 24 hours post operatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients listed for an ablation procedure for treatment of atrial fibrillation or flutter at TGH requiring sedation provided by an anesthetist
  • Valid consent

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451227


Locations
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Canada, Ontario
Toronto General Hospital, Univerity health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: George Djaiani, MD Toronto General Hospital, University Health Network
Publications:

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Responsible Party: Jo Carroll, Manager Anesthesia Research, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03451227    
Other Study ID Numbers: 13-6972-B
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jo Carroll, University Health Network, Toronto:
Sedation, Analgesia
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics