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

Tendulkar 2017.

Methods RCT, parallel design
Participants Total number of randomized participants: 60
Inclusion criteria: scheduled for surgery under GA; normotensive; ASA status I or II; 20‐70 years of age; either sex
Exclusion criteria: ≥ ASA status III; pregnant; severe left ventricular dysfunction; bronchial asthma or COPD; high risk for stroke; pre‐exisiting AF or high‐degree atroventricular block; pacemaker dependency
Type of surgery: type of surgery not specified (we assumed non‐cardiac)
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (SD): 43.76 (± 13.33) years

  • Gender, M/F: 19/11


Control group (standard care)
  • Age, mean (SD): 39.86 (± 12.59) years

  • Gender, M/F: 13/17


Country: India
Setting: single centre; hospital
Interventions Intervention group (esmolol)
  • Randomized, n = 30; losses = 0; analysed, n = 30 (use of ITT analysis not reported)

  • Details: injection of esmolol 1.5 mg/kg, slow IV bolus, given 2 min before extubation


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

  • Details: no study drugs were given

Outcomes Outcomes measured/reported by study authors: haemodynamic parameters; bradycardia (HR < 60 bpm; treated with atropine); hypotension (SBP < 80 mmHg; treated with mephentermine); coughing response to extubation; sedation scores
Outcomes relevant to the review: bradycardia (see notes below); hypotension
Notes Funding/declarations of interest: not reported
Study dates: July 2014‐August 2016
Notes:
  • study included an additional group (dexmedetomidine), which we did not include in the review

  • we could not be certain whether incidences of bradycardia were fully reported for the esmolol and standard care groups (data were available only for the dexmedetomidine group)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomization
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label trial
Blinding of outcome assessors (detection bias) 
 All outcomes High risk Open‐label trial
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