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

Miyazaki 2009.

Methods RCT, parallel group
Participants Total number of randomized participants: 63
Inclusion criteria: elderly (> 70 years of age); with or without hypertension; scheduled for surgery under GA
Exclusion criteria: ASA status III, IV or V; atrioventricular block > 1st degree; history of drug allergy; asthma; bronchospasm; COPD; coronary artery disease; HR < 50 bpm; SBP < 80 mmHg 1 min before administration of landiolol
Type of surgery: orthopaedic or gynaecological surgery
Baseline characteristics
Intervention group (landiolol ‐ hypertensive participants)
  • Age, mean (SD): 74 (± 4) years


Intervention group (landiolol ‐ normotensive participants)
  • Age, mean (SD): 73 (± 3) years


Control group (placebo ‐ hypertensive participants)
  • Age, mean (SD): 75 (± 4) years


Control group (placebo ‐ normotensive participants)
  • Age, mean (SD): 76 (± 5) years


Country: Japan
Setting: single centre; hospital
Interventions Intervention group (landiolol ‐ hypertensive and normotensive participants)
  • Randomized, n = 32; losses = 0; analysed, n = 32 (use of ITT analysis not reported)

  • Details: landiolol infusion 0.125 mg/kg/min for 1 min started during emergence from anaesthesia, then decreased to 0.04 mg/kg/min until extubation


Control group (placebo ‐ hypertensive and normotensive participants)
  • Randomized, n = 31; losses = 0; analysed, n = 31

  • Details: normal saline given same as the intervention group

Outcomes Outcomes measured/reported by study authors: haemodynamic parameters; bradycardia (HR < 50 bpm)
Outcomes relevant to the review: bradycardia
Notes Funding/declarations of interest: not reported
Study dates: not reported
Notes:
  • study investigators stratified randomized participants who had hypertension or who were normotensive into landiolol or control group, thus reporting four groups. We combined data in analysis for hypensive and normotensive participants

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of a random‐number table
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "All persons present during the study were blinded to the identity of the infusion being administered"
Blinding of outcome assessors (detection bias) 
 All outcomes Low risk See above
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No apparent losses
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