Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

Research output: Contribution to journalJournal articlepeer-review

  • Anne Benedicte Juul
  • Jørn Wetterslev
  • Christian Gluud
  • Allan Kofoed-Enevoldsen
  • Gorm Jensen
  • Torben Callesen
  • Peter Nørgaard
  • Kim Fruergaard
  • Morten Bestle
  • Rune Vedelsdal
  • André Miran
  • Jon Jacobsen
  • Jakob Roed
  • Maj-Britt Mortensen
  • Lise Jørgensen
  • Jørgen Jørgensen
  • Marie-Louise Rovsing
  • Pernille Lykke Petersen
  • Pott, Frank Christian
  • Merete Haas
  • Rikke Albret
  • Lise Lotte Nielsen
  • Gun Johansson
  • Pia Stjernholm
  • Yvonne Mølgaard
  • Nikolai Bang Foss
  • Jeanie Elkjaer
  • Bjørn Dehlie
  • Klavs Boysen
  • Dusanka Zaric
  • Anne Munksgaard
  • Jørn Bo Madsen
  • Bjarne Øberg
  • Boris Khanykin
  • Tine Blemmer
  • Stig Yndgaard
  • Grazyna Perko
  • Lars Peter Wang
  • Per Winkel
  • Hilden, Jørgen
  • Per Jensen
  • Nader Salas
  • DIPOM Trial Group
  • AB Juul
  • J Wetterslev
  • C Gluud
  • Gorm Jensen
  • Foss, Nicolai Bang
  • Pott, Frank Christian
  • Dusanka Zaric
  • Per Jensen
  • DIPOM Trial Group
Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome measures The composite primary outcome measure was time to all cause mortality, acute myocardial infarction, unstable angina, or congestive heart failure. Secondary outcome measures were time to all cause mortality, cardiac mortality, and non-fatal cardiac morbidity. Results Mean duration of intervention was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of 459 patients in the placebo group (20%) (hazard ratio 1.06, 0.80 to 1.41) during a median follow-up of 18 months (range 6-30). All cause mortality was 16% (74/462) in the metoprolol group and 16% (72/459) in the placebo group (1.03, 0.74 to 1.42). The difference in risk for the proportion of patients with serious adverse events was 2.4% (- 0.8% to 5.6%). Conclusions Perioperative metoprolol did not significantly affect mortality and cardiac morbidity in these patients with diabetes. Confidence intervals, however, were wide, and the issue needs reassessment. Trial registration Current Controlled Trials ISRCTN58485613 [controlled-trials.com] .
Original languageEnglish
JournalB M J
Volume332
Issue number7556
Pages (from-to)1482
ISSN0959-8146
DOIs
Publication statusPublished - 24 Jun 2006

Bibliographical note

Keywords: Adrenergic beta-Antagonists; Adult; Aged; Delayed-Action Preparations; Diabetes Complications; Double-Blind Method; Female; Hemodynamics; Humans; Intraoperative Care; Male; Metoprolol; Middle Aged; Patient Compliance; Surgical Procedures, Operative; Treatment Outcome

ID: 14309267