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

Harasawa 2006.

Methods RCT, parallel design
Participants Total number of randomized participants: 32
Inclusion criteria: undergoing surgery for intracranial or maxillofacial tumours under GA; ASA I or II; intraoperative HR > 90 bpm for > 5 min and SBP > 100 mmHg
Exclusion criteria: > 75 years of age; heart disease including arrhythmias; bronchial asthma; receiving preoperative cardiovascular medications
Type of surgery: surgery for intracranial or maxillofacial tumours
Baseline characteristics
Intervention group (landiolol 0.1 mg/kg)
  • Age, mean (SD): 51 (± 16) years

  • Gender, M/F: 4/4


Intervention group (landiolol 0.2 mg/kg)
  • Age, mean (SD): 44 (± 14) years

  • Gender, M/F: 4/4


Intervention group (landiolol 0.3 mg/kg)
  • Age, mean (SD): 45 (± 17) years

  • Gender, M/F: 4/4


Control group (placebo)
  • Age, mean (SD): 48 (± 14) years

  • Gender, M/F: 4/4


Country: Japan
Setting: single centre; university hospital
Interventions Intervention group (landiolol 0.1 mg/kg)
  • Randomized, n = 8; losses = 0; analysed, n = 8 (use of ITT analysis not reported)

  • Details: started 2 h after start of surgery, if HR > 90 bpm for > 5 min and SBP > 100 mmHg, 0.1 mg/kg landiolol, IV, over 10 seconds


Intervention group (landiolol 0.2 mg/kg)
  • Randomized, n = 8; losses = 0; analysed, n = 8 (use of ITT analysis not reported)

  • Details: using 0.2 mg/kg landiolol, same as other intervention groups


Intervention group (landiolol 0.3 mg/kg)
  • Randomized, n = 8; losses = 0; analysed, n = 8 (use of ITT analysis not reported)

  • Details: using 0.3 mg/kg landiolol, same as other intervention groups


Control group (placebo)
  • Randomized, n = 8; losses = 0; analysed, n = 8 (use of ITT analysis not reported)

  • Details: 0 mg/kg (described as a placebo in abstract), same as the intervention groups

Outcomes Outcomes measured/reported by study authors: haemodynamic variables; hypotension (SBP < 80 mmHg); bradycardia (HR < 50 bpm); ischaemic changes on ECG
Outcomes relevant to the review: hypotension; bradycardia
Notes Funding/declarations of interest: not reported
Study dates: not reported
Note:
  • we combined data in analysis for all landiolol groups

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 Described as placebo‐controlled, but blinding is not reported
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