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. 2019 Sep 26;2019(9):CD013438. doi: 10.1002/14651858.CD013438

Jakobsen 1986.

Methods RCT, parallel design
Participants Total number of randomized participants: 20
Inclusion criteria: scheduled for middle ear or nasal septum surgery, without evidence of cardiopulmonary disease
Exclusion criteria: not reported
Type of surgery: middle ear or nasal septum surgery
Baseline characteristics
Intervention group (metoprolol)
  • Age, mean (SD): 29.4 (± 3.8) years


Control group (placebo)
  • Age, mean (SD): 36.4 (± 3.4) years


Country: Denmark
Setting: single centre; hospital
Interventions Intervention group (metoprolol)
  • Randomized, n = 10; losses = 1 (due to protocol violation with premedication); analysed, n = 9 (ITT analysis was not used)

  • Details: metoprolol 50 mg given orally the day before surgery, then 100 mg given with premedication before anaesthesia


Control group (placebo)
  • Randomized, n = 10; losses = 0; analysed, n = 10

  • Details: placebo given same as the intervention

Outcomes Outcomes measured/reported by study authors: doses and concentration of anaesthetic agents; haemodynamic variables; blood loss; recovery times; PONV, and other side effects in the PACU
Outcomes relevant to the review: bradycardia (see notes)
Notes Funding/declarations of interest: study drugs provided by Hässle, Denmark
Study dates: not reported
Note:
  • study authors reported that "some patients receiving metoprolol developed a relative bradycardia before the induction of anaesthesia". Because number of events were not reported, we could not use these data in analysis

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Use of an envelope system to randomize participants. Insufficient information
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Anaesthetists and surgeons were unaware of group allocation
Blinding of outcome assessors (detection bias) 
 All outcomes Low risk Group allocation was concealed until after study results were available, and therefore we assumed that outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Loss of 1 participant because of protocol violation (with premedication)
Selective reporting (reporting bias) Unclear risk Study authors did not report prospective clinical trial registration or publication of a protocol. It was not feasible to effectively assess risk of reporting bias
Other bias Low risk Not detected