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

Inoue 2010.

Methods RCT, parallel design
Participants Total number of randomized participants: 90
Inclusion criteria: ASA I to II; scheduled for gynaecological procedures in the supine position
Exclusion criteria: symptomatic ischaemic heart disease, hepatic or renal disease; coagulopathy; administered vasodilator medications; unable to measure tympanic temperature; contraindications to beta‐blockers
Type of surgery: elective gynaecological procedures
Baseline characteristics
Intervention group (landiolol)
  • Age, mean (SD): 62 (± 14) years


Intervention group (esmolol)
  • Age, mean (SD): 56 (± 13) years


Control group (placebo)
  • Age, mean (SD): 57 (± 14) years


Country: Japan
Setting: single centre; hospital
Interventions Intervention group (landiolol)
  • Randomized, n = 30; losses = 4 (due to problems with blood sample collection); analysed, n = 26

  • Details: 0.2 mg/kg, adjusted to 0.1 mL/kg of solution, given as a single bolus immediately prior to induction of GA


Intervention group (esmolol)
  • Randomized, n = 30; losses = 2 (due to problems with blood sample collection); analysed, n = 28

  • Details: 1 mg/kg, adusted to 0.1 mL/kg of solution, given same as landiolol group


Control group (placebo)
  • Randomized, n = 30; losses = 1 (due to problems with blood sample collection); analysed, n = 29

  • Details: normal saline 0.1 mL/kg, given same as the intervention group

Outcomes Outcomes measured/reported by study authors: temperature changes; haemodynamic variables; bradycardia (not defined); hypotension (not defined); bronchospasm
Outcomes relevant to the review: bradycardia; hypotension
Notes Funding/declarations of interest: funding sources not reported. Study authors declare no conflicts
Study dates: not reported
Notes:
  • we combined data for both beta‐blocker groups in analysis

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomly assigned (closed envelope technique)"
Comment: insufficient information
Allocation concealment (selection bias) Unclear risk Use of "closed" envelopes; however, no additional information is specified
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Attending anesthesiologists were blinded to the test drugs"
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk Not specified
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Small number of losses with reasons reported
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