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

Yamazaki 2005.

Methods RCT, parallel design
Participants Total number of randomized participants: 64
Inclusion criteria: undergoing elective non‐cardiac surgery under GA
Exclusion criteria: history of cardiovascular disease; diabetes mellitis; disorders known to affect autonomic function; people taking medications known to affect cardiovascular function
Type of surgery: type not specified
Baseline characteristics
Intervention group (landiolol 0.1 mg/kg)
  • Age, mean (SD): 49.0 (± 16.4) years


Intervention group (landiolol 0.3 mg/kg)
  • Age, mean (SD): 47.4 (± 14.5) years


Control group (placebo)
  • Age, mean (SD): 50.5 (± 16.4) years


Country: Japan
Setting: hospital; single centre
Interventions Intervention group (landiolol 0.1 mg/kg)
  • Randomized, n = 22; losses = 0; analysed, n = 22 (use of ITT analysis not reported)

  • Details: landiolol 0.1 mg/kg, IV, over 10 seconds, during anaesthesia


Intervention group (landiolol 0.3 mg/kg)
  • Randomized, n = 20; losses = 0; analysed, n = 20 (use of ITT analysis not reported)

  • Details: landiolol 0.3 mg/kg, IV, over 10 seconds, during anaesthesia


Control group (placebo)
  • Randomized, n = 22; losses = 0; analysed, n = 22

  • Details: saline given, same as the intervention group

Outcomes Outcomes measured/reported by study authors: haemodynamic variables; bradycardia and hypotension (not defined)
Outcomes relevant to the review: bradycardia, hypotension
Notes Funding/declarations of interest: not reported
Study dates: not reported
Notes:
  • we combined both landiolol groups in analysis

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Saline is given in the control group. However, study authors did not report whether anaesthetists were blinded to the agent
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk Not specified
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