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

Meftahuzzaman 2014.

Methods RCT, parallel group
Participants Total number of randomized participants: 60
Inclusion criteria: male or female; weighing 35‐60 kg; 15‐55 years of age; ASA I or II; scheduled for elective surgical procedures
Exclusion criteria: predicted difficult intubation; hypertension; ischaemic heart disease; compensatory tachycardia; baseline HR < 60 bpm or SBP < 100 mmHg; chronic obstructive airway disease; taking medication with cardiovascular effects
Type of surgery: elective surgery (type not specified; we assumed non‐cardiac)
Baseline characteristics
Intervention group (labetalol)
  • Age, mean (SD): 38.5 (± 11.23) years

  • Gender, M/F: 15/15


Control group (placebo)
  • Age, mean (SD): 35.33 (± 10.41) years

  • Gender, M/F: 15/15


Country: Bangladesh
Setting: single centre; hospital
Interventions Intervention group (labetalol)
  • Randomized, n = 30; losses = 0; analysed, n = 30 (use of ITT analysis not reported)

  • Details: 0.25 mg/kg labetalol diluted with 10 mL normal saline, IV; 3 min prior to intubation over a period of 30 seconds


Control group (placebo)
  • Randomized, n = 30; losses = 0; analysed, n = 30

  • Details: 10 mL normal saline, given same as the intervention group

Outcomes Outcomes measured/reported by study authors: haemodynamic variables; bradycardia (HR < 50 bpm)
Outcomes relevant to the review: bradycardia
Notes Funding/declarations of interest: not reported
Study dates: January 2012‐June 2013
Note:
  • study included an additional arm (fentanyl), which we did not include in the review

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified
Allocation concealment (selection bias) Low risk Use of sequentially, numbered, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Described as placebo‐controlled double‐blinded study, and therefore we assumed that personnel were blinded
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk No 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