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

Inada 1989.

Methods RCT, parallel design
Participants Total number of randomized participants: 30
Inclusion criteria: adults, 21‐71 years of age, scheduled for elective surgery under GA with tracheal intubation
Exclusion criteria: congestive heart failure; unstable angina; bronchospastic disease on bronchodilators; atrioventricular block; severe hepatic dysfunction; ASA physical status IV; concurrent alpha‐ or beta‐adrenergic drug administration
Type of surgery: elective surgery (type not specified ‐ we assumed non‐cardiac)
Baseline characteristics
Intervention group (labetalol 5 mg)
  • Age, mean (SD): 52 (± 5) years

  • Gender, M/F: 5/5

  • ASA status I/II/III: 2/7/1

  • History of MI, n: 0

  • History of hypertension, n: 3

  • History of COPD, n: 0


Intervention group (labetalol 10 mg)
  • Age, mean (SD): 53 (± 5) years

  • Gender, M/F: 4/6

  • ASA status I/II/III: 2/7/1

  • History of MI, n: 0

  • History of hypertension, n: 2

  • History of COPD, n: 0


Control group (placebo)
  • Age, mean (SD): 49 (± 5) years

  • Gender, M/F: 55

  • ASA status I/II/III: 3/7/0

  • History of MI, n: 2

  • History of hypertension, n: 1

  • History of COPD, n: 2


Country: USA
Setting: single centre; hospital
Interventions Intervention group (labetalol 5 mg)
  • Randomized, n = 10; losses = 0; analysed, n = 10 (use of ITT analysis not reported)

  • Details: before induction of GA, 2 mL syringe, labetalol 5 mg


Intervention group (labetalol 10 mg)
  • Randomized, n = 10; losses = 0; analysed, n = 10

  • Details: before induction of GA, 2 mL syringe, labetalol 10 mg


Control group
  • Randomized, n = 10; losses = 0; analysed, n = 10

  • Details: saline, same as the intervention groups

Outcomes Outcomes measured/reported by study authors: haemodynamic response; dysrhythmias (ventricular begeminy, ventricular extrasystoles); hypotension (not defined); bradycardia (not defined
Outcomes relevant to the review: hypotension, bradycardia
Notes Funding/declarations of interest: drug preparation supported by funds from Shering Corporation
Study dates: not reported
Notes:
  • in analysis, we combined data from both labetalol groups

  • study included an additional group (lidocaine), which we did not include in this review

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. Participants received study drugs from "identical syringes" intravenously: content of syringes not predictable in advance
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 Low risk Not detected