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)
Control group (placebo)
Country: France Setting: hospital; single centre |
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Interventions |
Intervention group (esmolol)
Control group (placebo)
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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 |
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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 |
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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 |