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. 2019 Nov 21;2019(11):CD011931. doi: 10.1002/14651858.CD011931.pub2

Song 2016.

Methods Study design: randomized controlled trial (2 arms)
Study duration: 2006 to 2009
Study setting: hospital, single centre, China
Participants Adults undergoing elective supratentorial craniotomy (n = 60)
Inclusion criteria
  1. ASA I to III adults undergoing above surgery


Exclusion criteria
  1. History of ischaemic heart disease or conduction defects

  2. Pulmonary disease

  3. Hepatic disease

  4. Renal impairment

  5. Cognitive defect

  6. Long‐tern use of beta blockers, angiotension‐converting enzyme inhibitors, analgesics, sedatives or antidepressants

  7. Allergy to study drugs


Mean age, range (years)
  1. 39 (18 to 60)


Numbers allocated to each arm
  1. Group intervention (n = 30)

  2. Group control (n = 30)


Male gender
  1. Group intervention: 17/25 (participants analysed)

  2. Group control: 15/27 (participants analysed)

Interventions Technique and timing
Intravenous infusion of dexmedetomidine 0.5 mcg/kg/hr for 10 minutes before induction of anaesthesia, then 0.2 to 0.5 mcg/kg/hr until skin closure versus placebo
Dosage
As above
Outcomes Not clear from the report, which outcomes were primary and which were secondary
  1. Postoperative pain using the NRS – numerical rating scale (measured at 1, 2 ,4, 6, 8, 12 and 24 hours)

  2. Sedation – Ramsey Scale – up to 24 hours postoperatively

  3. Morphine consumption – up to 23 hours postoperatively

  4. Respiratory depression

  5. Hypotension

  6. Bradycardia

Notes Funding
None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random number table
Allocation concealment (selection bias) Low risk Quote: ''an anaesthesia nurse prepared the syringe according to the computer‐generated random number and was the only person who knew whether the active drug or placebo was administered''.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: ''an anaesthesia nurse prepared the syringe according to the computer‐generated random number and was the only person who knew whether the active drug or placebo was administered''.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not clear if the anaesthesia nurse who prepared the study drugs was involved in assessing outcomes or not
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 3 participants (1 in the intervention group and 2 in the control group) did not receive their allocated treatments as their surgery was cancelled.
5 participants were lost to follow‐up after receiving their allocated treatments as they were not extubated after surgery (4 in the invention group and 1 in the control group).
An intention‐to‐treat analysis was not performed.
Selective reporting (reporting bias) Unclear risk The lack of clarity regarding outcome priorities makes it difficult to exclude reporting bias.
Other bias Unclear risk Small study