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

Unal 2008.

Methods RCT, parallel design
Participants Total number of randomized participants: 45
Inclusion criteria: ASA status I or II; scheduled for lumbar disc surgery
Exclusion criteria: pregnant women; HR < 60 bpm; SBP < 100 mmHg; serious hepatic, renal and cardiovascular diseases; congestive heart failure; atrioventricular block; sick sinus syndrome; drug allergy and past history of beta‐blocker intolerance; bronchospasm; asthma; COPD; haemotological disorders; receiving beta‐blockers and calcium channel blockers
Type of surgery: lumbar disc surgery
Baseline characteristics
Intervention group (esmolol 0.1 mg/kg/min)
  • Age, mean (SD): 50.3 (± 17.1) years

  • Gender, M/F: 7/8

  • ASA status I/II: 8/7


Intervention group (esmolol 0.2 mg/kg/min)
  • Age, mean (SD): 48.1 (± 16.2) years

  • Gender, M/F: 7/8

  • ASA status I/II: 6/9


Control group (placebo)
  • Age, mean (SD): 50.3 (± 12.2) years

  • Gender, M/F: 8/7

  • ASA status: 9/6


Country: Turkey
Setting: single centre; hospital
Interventions Intervention group (esmolol 0.1 mg/kg/min)
  • Randomized, n = 15; losses = 0; analysed, n = 15

  • Details: bolus dose 0.5 mg/kg over 4 min, at the end of surgery, before extubation. Then infusion of esmolol 0.1 mg/kg/min continued until 10 min after extubation


Intervention group (esmolol 0.2 mg/kg/min)
  • Randomized, n = 15; losses = 0; analysed, n = 15

  • Details: bolus dose 0.5 mg/kg over 4 min, at the end of surgery, before extubation. Then infusion of esmolol 0.2 mg/kg/min continued until 10 min after extubation


Control group (placebo)
  • Randomized, n = 15; losses = 0; analysed, n = 15

  • Details: 0.9% saline, given same as the intervention groups

Outcomes Outcomes measured/reported by study authors: haemodynamic variables, hypotension, hypertension
Outcomes relevant to the review: hypotension
Notes Funding/declarations of interest: not reported
Study dates: not reported
Note:
  • we combined both esmolol 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 Quote: "Esmolol and SP (serum physiological) solutions were prepared without the knowledge of the person who would keep the records"
Comment: it was unclear whether 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 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