Tachyarrhythmia Clinical Trial
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
Verified date | May 2019 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | May 14, 2019 |
Est. primary completion date | March 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital, Univerity health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. 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 | |
Primary | 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) |
up to 24 hours | |
Secondary | 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 |
up to 24 hours | |
Secondary | 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 |
up to 24 hours | |
Secondary | 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 |
up to 48 hours | |
Secondary | Recovery time | Time from stopping infusion to a SAS score of =4 | up to 24 hours | |
Secondary | 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 | up to 24 hours | |
Secondary | Analgesia requirements | Quantity of opioids required i. Intraoperatively ii. In recovery iii. In the first 24 hours post op | up to 24 hours | |
Secondary | Post operative nausea and vomiting (PONV) | Subjective or objective evidence of PONV lasting > 30 mins Antiemetic therapy administered |
up to 24 hours | |
Secondary | Itch | Any complaints of itch during the procedure and 24 hours post operatively | up to 24 hours |
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