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

Louizos 2007.

Methods RCT, parallel design
Participants Total number of randomized participants: 162
Inclusion criteria: cigarette smokers; ASA I‐III; undergoing elective microlaryngeal surgery under GA; having smoked an average of 20‐30 cigarettes daily for > 10 years
Exclusion criteria: average in‐hospital HR < 55 bpm or SBP < 100 mmHg; COPD; sick sinus syndrome, conduction abnormalities on the ECG; cardiac failure; receive monoamine oxidase inhibitors or reserpine
Type of surgery: elective microlaryngeal surgery
Baseline characteristics
Intervention group (esmolol 1 mg/kg)
  • Age, mean (SD): 44 (± 8) years

  • Gender, M/F: 28/26


Intervention group (esmolol 2 mg/kg)
  • Age, mean (SD): 43 (± 11) years

  • Gender, M/F: 26/29


Control group (placebo)
  • Age, mean (SD): 41 (± 8) years

  • Gender, M/F: 26/27


Country: Greece
Setting: single centre; hospital
Interventions Intervention group (esmolol 1 mg/kg)
  • Randomized, n = 54; losses = 0; analysed, n = 54 (use of ITT analysis not reported)

  • Details: 1 mg/kg esmolol in 30 mL normal saline given during induction of anaesthesia


Intervention group (esmolol 2 mg/kg)
  • Randomized, n = 55; losses = 0; analysed, n = 55

  • Details: 2 mg/kg esmolol in 30 mL normal saline given during induction of anaesthesia


Control group (placebo)
  • Randomized, n = 53; losses = 0; analysed, n = 53

  • Details: 30 mL normal saline given during inductin of anaesthesia

Outcomes Outcomes measured/reported by study authors: haemodynamic variables; tachycardia (type of tachycardia not defined); bronchospasm, bradycardia, hypotension, hypertension, volume of rescue esmolol
Outcomes relevant to the review: hypotension, bradycardia
Notes Funding/declarations of interest: not reported
Study dates: not reported
Notes:
  • 3 participants were withdrawn from the study before initiation of treatment. Study authors did not report to which group these participants were allocated. We did not include these participants in the number randomized

  • we combined data for both esmolol groups in analysis

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specfied
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Anaesthetists were blinded to the type of drug
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk Not specified
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3 participants were withdrawn before initiation of study intervention. No other 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 High risk Participants in either group were treated with esmolol in the event of hypertension, arterial blood pressure and tachycardia. This may influence outcome data for some control group participants