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

Ugur 2007.

Methods RCT, parallel design
Participants Total number of randomized participants: 60
Inclusion criteria: 20‐50 years of age; ASA status I or II; undergoing elective surgery under GA
Exclusion criteria: history of cardiovascular disease, diabetes mellitus, COPD, renal or hepatic failure; taking drugs that affect the cardiovascular system; SBP < 100 mmHg or > 160 mmHg; DBP < 50 mmHg or > 110 mmHg; HR < 50 bpm or > 120 bpm
Type of surgery: elective surgery (type of surgery not specified ‐ we assumed non‐cardiac)
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (SD): 41.76 (± 12.6) years

  • Gender, M/F: 10/20


Control group (placebo)
  • Age, mean (SD): 36.96 (± 13.3) years

  • Gender, M/F: 9/21


Country: Turkey
Setting: hospital; single centre
Interventions Intervention group (esmolol)
  • Randomized, n = 30; losses = 0; analysed, n = 30

  • Details: 1.5 mg/kg esmolol given after induction of anaesthesia and before tracheal intubation


Control group (placebo)
  • Randomized, n = 30; losses = 0; analysed, n = 30

  • Details: 5 mL 5% dextrose, given the same as the intervention group

Outcomes Outcomes measured/reported by study authors: haemodynamic variables; bradycardia (HR < 50 bpm); bronchospasm; arrhythmia (not defined); abnormal ST segments on ECG
Outcomes relevant to the review: bradycardia
Notes Funding/declarations of interest: no funding; study authors declare no conflicts of interest
Study dates: not reported
Note:
  • study included 2 additional study groups (fentanyl; and lidocaine), which we did not include in the review

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomization chart
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded randomized trial
Blinding of outcome assessors (detection bias) 
 All outcomes Low risk Participants, and anaesthetists who recorded outcome data, were blinded to group allocation
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