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

Gibson 1988.

Methods RCT, parallel design
Participants Total number of randomized participants: 40
Inclusion criteria: neurosurgical patients who exhibited at least 20% increase in SBP above average ward pressure on emergence from anaesthesia
Exclusion criteria: unsuitable for beta‐blocker treatment, HR < 60 bpm, atrioventricular block, sick sinus syndrome, prior evidence of congestive heart failure, history of bronchospasm or asthma, impaired renal or hepatic function, receiving beta‐blockers or calcium channel blockers within 4 h of entry into study
Type of surgery: different neurosurgical interventions
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (SD): 51.2 (± 17.5) years

  • Gender, M/F: 15/6

  • History of hypertension, n: 8


Control group (placebo)
  • Age, mean (SD): 51.7 (± 15.7)

  • Gender, M/F: 8/11

  • History of hypertension, n: 6


Country: USA
Setting: single centre; hospital
Interventions Intervention group (esmolol)
  • Randomized, n = 21; losses = 0; analysed, n = 21 (use of ITT analysis was not reported)

  • Details: during anaesthesia, continuous infusion with a loading dose of esmolol 40 mg/min for 4 min, followed by infusion rate of 24 mg/min. Continued until 10 min after extubation


Control group (placebo)
  • Randomized, n = 19; losses = 0; analysed, n = 19

  • Details: given same as intervention

Outcomes Outcomes measured/reported by study authors: haemodynamic variables, hypertension, hypotension (not defined), bradycardia (not defined); nausea and vomiting
Outcomes relevant to the review: bradycardia and hypotension (see notes below)
Notes Funding/declarations of interest: not reported
Study dates: not reported
Note:
  • we did not include data for bradycardia and hypotension in analysis because we could not be certain whether these outcomes were measured in both groups. Study authors reported that 2 participants in the esmolol group had mild to moderate hypotension that required discontinuation of treatment, and one participant in the placebo group experienced bradycardia

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 Low risk Randomized, placebo‐controlled, double‐blind trial
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 High risk An antihypertensive agent (hydralazine or labetalol) was given intraoperatively to participants in either group to control BP. It is unclear how many participants in the control group received labetalol, which may influence outcome data