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

May 14, 2019 updated by: Jo Carroll, University Health Network, Toronto

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital, Univerity health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 hours
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)
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 hours
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
up to 24 hours
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
up to 48 hours
Recovery time
Time Frame: up to 24 hours
Time from stopping infusion to a SAS score of ≥4
up to 24 hours
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
up to 24 hours
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
up to 24 hours
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
up to 24 hours
Itch
Time Frame: up to 24 hours
Any complaints of itch during the procedure and 24 hours post operatively
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

March 12, 2018

Study Completion (Actual)

May 14, 2019

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-6972-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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