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

Bhattacharjee 2016.

Methods RCT, parallel design
Participants Total number of randomized participants: 40
Inclusion criteria: ASA status I or II; 20‐60 years of age; undergoing elective laparoscopic cholecystectomy under GA
Exclusion criteria: pre‐existing hypertension; bronchial asthma; diabetes; sinus bradycardia; severe hepatic, renal, endocrine and cardiac dysfunction. Participants in whom surgery could not be completed laparoscopically or had open cholecystectomy were excluded
Type of surgery: elective laparoscopic cholecystectomy
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (SD): 28.4 (± 5.12) years

  • Gender, M/F: 8/12


Control group (placebo)
  • Age, mean (SD): 30.4 (± 5.24) years

  • Gender, M/F: 8/12


Country: India
Setting: single centre; hospital
Interventions Intervention group (esmolol)
  • Randomized, n = 20; losses = 0; analysed, n = 20 (use of ITT analysis not reported)

  • Details: bolus dose of 500 µg/kg esmolol IV, before pneumoperitoneum, during anaesthesia; followed by infusion of 100 µg/kg/min. Intervention given intraoperatively only


Control group (placebo)
  • Randomized, n = 20; losses = 0; analysed, n = 20 (use of ITT analysis not reported)

  • Details: saline given same as the intervention group

Outcomes Outcomes measured/reported by study authors: haemodynamic variables; adverse events (to include bradycardia, hypotension, and hypertension) during postoperative period in the PACU; recovery times
Outcomes relevant to the review: bradycardia (HR < 60 bpm); hypotension (MAP < 60 mmHg)
Notes Funding/declarations of interest: no sources of funding and authors declare no conflicts
Study dates: not reported
Note:
  • study included a 3rd arm (dexmedetomidine), which we did not include in this review

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of a computer‐derived random‐number sequence
Allocation concealment (selection bias) Low risk See above
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Study is described as single‐blinded. It is not clear if the anaesthetists are blinded to treatment groups
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk No details
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