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. 2019 Mar 1;2019(3):CD006715. doi: 10.1002/14651858.CD006715.pub3

Nygard 2004.

Methods Parallel RCT
Ethics committees: approved by the Scientific Ethics Committees for Copenhagen and Frederiksberg (KF 02‐124/98), the Danish Data Protection Agency, and the Danish Medicines Agency
Informed consents: written informed consents obtained
Site: Copenhagen, Denmark
Setting: university hospital
Dates of data collection: not reported
Funding: supported by The Danish Heart Foundation (grant no. 99‐2‐3‐79‐22764 and no. 99‐1‐5‐92‐22709) and an unrestricted grant from AstraZeneca, Denmark
Registration: unspecified
Participants 163 participants; mean age: 64.4 years; sex distribution: 18 females and 145 females
Inclusion criteria

  1. Patients scheduled for elective CABG; sinus rhythm


Exclusion criteria

  1. Off‐pump surgery

  2. Implanted pacemaker

  3. Use of amiodarone within 4 months of enrolment

  4. History of amiodarone toxicity

  5. Known thyroid disease

  6. Liver disease

  7. Uncontrolled heart failure

  8. Resting heart rate < 50 beats/min in the absence of medical therapy known to slow the heart rate

  9. Anticoagulant medication with warfarin

  10. Coagulopathy

  11. Pregnancy

  12. Use of antiarrhythmic drugs other than alpha₁‐receptor antagonists

  13. Calcium channel antagonists

  14. Digoxin.
Interventions Intervention

  1. Epidural analgesia with (N = 35) or without amiodarone (N = 44)


Comparator

  1. Systemic analgesia with (N = 36) or without amiodarone (N = 48)


Induction: midazolam, fentanyl, and pancuronium
Maintenance: isoflurane and fentanyl or epidural analgesia
Surgery: CABG with CPB
Outcomes Relevant to this review

  1. Risk of mortality

  2. Risk of atrial fibrillation or atrial flutter

  3. Haemodynamic variables


Other

  1. Length of hospital stay
Notes Correspondence: letter sent 16 March 2018; no reply
Conflict of interest: none other than the grants received
DOI: 10.1053/j.jvca.2004.08.006
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned to 4 groups; randomization was 1:1:1:1. Randomization list was generated from a computerized table of random numbers
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "the study was conducted in an open manner"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "the study was conducted in an open manner"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Of the 196 patients included, 163 were evaluated: 18 patients had surgery cancelled, and 4 patients had a change in surgical procedure. One withdrew consent preoperatively, and 6 withdrew consent postoperatively. One patient had a stroke before surgery, and in 1 patient placement of the epidural catheter was unsuccessful. Two patients were excluded because of protocol violations
Selective reporting (reporting bias) Low risk Appears to be free of other sources of bias. Sample size calculation stated
Other bias Unclear risk Not in intention‐to‐treat
Groups had similar demographic data