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

Van den Berg 1998.

Methods RCT, parallel design
Participants Total number of randomized participants: 80
Inclusion criteria: ASA I‐III; middle‐aged to elderly healthy people; receiving treatment for diabetes, hypertension, ischaemic heart disease, or a combination of these diseases; scheduled for cataract extraction under GA because they were considered unsuitable for peribulbar analgesia due to senility, language barrier, chronic cough, renal failure, or an estimated inability to remain immobile in the supine position during surgery
Exclusion criteria: asthma
Type of surgery: cataract extraction under GA
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (SD): 67 (± 11) years

  • Gender, M/F: 27/13

  • History of hypertension, n: 9

  • Preoperative use of beta‐blockers, n: 4


Control group (placebo)
  • Age, mean (SD): 65 (± 11) years

  • Gender, M/F: 21/19

  • History of hypertension, n: 4

  • Preoperative use of beta‐blockers, n: 2


Country: Saudi Arabia
Setting: single centre; hospital
Interventions Intervention group (esmolol)
  • Randomized, n = 40; losses = 0; analysed, n = 40 (use of ITT analysis not reported)

  • Details: 250 mg/mL esmolol IV given immediately after induction at rate of 4 mg/kg. Then 60 seconds before eye bandaging at rate of 2 mg/kg, then 60 seconds prior to extubation at rate of 2 mg/kg


Control group (placebo)
  • Randomized, n = 40; losses = 0; analysed, n = 40

  • Details: normal saline, given same as the intervention group

Outcomes Outcomes measured/reported by study authors: haemodynamic parameters; bradycardia (HR < 50 bpm and treated with atropine)
Outcomes relevant to the review: bradycardia (see notes below)
Notes Funding/declarations of interest: not reported
Study dates: January 1995‐April 1996
Note:
  • we did not include data for bradycardia in analysis because data were unclearly reported in study tables and text

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of block randomization
Allocation concealment (selection bias) Low risk Use of sealed envelopes, and preparation of syringes by anaesthetists were blinded to treatment groups
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Anaesthetists were blinded, use of coded syringes
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