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

Menigaux 2002.

Methods RCT, parallel design
Participants Total number of randomized participants: 50
Inclusion criteria: 18‐70 years of age; ASA status I or II; scheduled for elective non‐cranial surgery
Exclusion criteria: neurological, cardiac, or metabolic disease; chronic hypertension; asthma or reactive airway disease; cardiovascular or beta‐blocker medication; routine use of analgesics or hypnotic medication; drug or alcohol abuse; obesity
Type of surgery: elective non‐cranial surgery
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (range): 37 (19‐53) years

  • Gender, M/F: 15/10


Control group (placebo)
  • Age, mean (range): 36 (18‐54) years

  • Gender, M/F: 18/7


Country: France
Setting: hospital; single centre
Interventions Intervention group (esmolol)
  • Randomized, n = 25; losses = 0; analysed, n = 25

  • Details: during anaesthesia, bolus of esmolol 1 mg/kg followed by an infusion of 250 µg/kg/min


Control group (placebo)
  • Randomized, n = 25; losses = 0; analysed, n = 25

  • Details: comparable volume of saline given

Outcomes Outcomes measured/reported by study authors: BIS values; haemodynamic variables; response to laryngoscopy and intubation; hypotension (MAP < 60 mmHg); bradycardia (HR < 50 bpm)
Outcomes relevant to the review: bradycardia; hypotension
Notes Funding/declarations of interest: supported by NIH grant, the Joseph Down Foundation, and the Commonwealth of Kentucky Research Challenge Trust Fund. Authors declare no financial interests in the research
Study dates: not reported
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 Low risk Quote: "Patients and personnel involved in patient management and data collection were unaware of the group allocation"
Comment: to ensure blinding, hospital pharmacists prepared syringes
Blinding of outcome assessors (detection bias) 
 All outcomes Low risk Quote: "Patients and personnel involved in patient management and data collection were unaware of the group allocation"
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