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

Jangra 2016.

Methods RCT, parallel design
Participants Total number of randomized participants: 20
Inclusion criteria: ASA I or II; scheduled for endoscopic sinus surgery
Exclusion criteria: people on beta‐blockers and cardiovascular active drugs; major hepatic, renal or cardiac disease; haematological disorders; allergic to magnesium sulfate; history of neromuscular disorder; diabetic neuropathy; pregnancy; prior treatment with opioids or anticoagulants
Type of surgery: elective endoscopic sinus surgery
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (SD): 26.7 (± 8.3) years

  • Gender, M/F: 3/7

  • ASA status I/II: 10/0


Control group (placebo)
  • Age, mean (SD): 31.9 (± 9.0) years

  • Gender, M/F: 6/4

  • ASA status I/II: 9/1


Country: India
Setting: single centre; hospital
Interventions Intervention group (esmolol)
  • Randomized, n = 10; losses = 0; analysed, n = 10 (use of ITT analysis was not reported)

  • Details: esmolol 500 µg/kg/min as an IV bolus over 10 min, after induction of anaesthesia, then infusion at the rate of 100‐300 µg/kg/min. We assumed discontinuation was at the end of anaesthesia


Control group (placebo)
  • Randomized, n = 10; losses = 0; analysed, n = 10 (use of ITT analysis was not reported)

  • Details: normal saline given in same volumes as intervention group

Outcomes Outcomes measured/reported by study authors: hypotension (MAP < 50 mmHg); hypertension; need for additional hypotensive agents or vasopressors; reflex tachycardia and arrhythmias; bradycardia (not defined, and data not reported); bronchospasm (data not reported); arrhythmias; recovery times; blood loss; assessment of surgical field for bleeding
Outcomes relevant to the review: hypotension (see notes below)
Notes Funding/declarations of interest: no sources of support, and study authors declare no conflicts
Study dates: July 2007‐October 2008
Notes:
  • study included an additional group (magnesium sulphate), which we did not include in this review

  • we did not include data for hypotension in analysis because it was not clear whether study authors measured this outcome in the control group; study authors reported that no participants in the esmolol group had excessive hypotension

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of computerized programme for randomization
Allocation concealment (selection bias) Low risk See above
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants and surgeons were blinded to group allocation. However, study authors do not report whether anaesthetists were blinded to group allocation
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 Unclear risk Study authors noted that the duration of surgery and anaesthesia were less in the esmolol group. It is unclear whether this may influence results