Sieber 2010.

Methods	Design: Randomised controlled trial of light sedation during spinal anaesthesia for reducing postoperative delirium in elderly hip fracture patients Date of study: April 2005‐October 2008 Power calculation: Yes Frequency of outcomes assessment: Daily from second postoperative day Inclusion criteria: Aged 65 years and over undergoing hip fracture repair with spinal anaesthesia and propofol sedation Exclusion criteria: Contraindications to spinal anaesthesia, prior hip surgery, mental or language barriers that would preclude data collection, severe heart failure, severe COPD
Participants	Number in study: 114 Country: USA Setting: Hip fracture patients Age: Mean age 81.2 years (SD 7.6) in intervention group, 81.8 years (SD 6.7) in control group Sex: 70% female in intervention group, 75% female in control group Co‐morbidity: Mean Charlson comorbidity index score 1.6 (1.2) in intervention group, 1.4 (1.4) in control group Dementia: 37% in intervention group, 33% in control group
Interventions	Intervention: Sedation was provided during surgery by a propofol infusion targeted to a bispectral index (BIS) of 80 or higher in the light sedation group Control: Sedation was provided during surgery by a propofol infusion targeted to a bispectral index (BIS) of approximately 50 in the deep sedation group. In general, these targets render the light sedation group responsive to voice and the heavy sedation group unresponsive to noxious stimuli.
Outcomes	1. Incident delirium, measured using CAM 2. Duration of delirium 3. Length of admission 4. Mortality (in hospital, at 1‐year and overall) 5. Cognition using MMSE on postoperative day 2 6. Postoperative complications (Patients with >=1 complications)
Notes	Funding source: Not reported Declarations of interest: Not reported Light sedation group received significantly more midazolam (5.5 mg/kg vs 1.3 mg/kg, P = 0.02). Mean BIS in light sedation group 85.7 (11.3) vs 49.9 (13.5) control P < 0.001 Exclusion of patients with MMSE<15 limits generalisability of findings. Delirium excluded at enrolment
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	Method of concealing allocation not clearly described
Random sequence generation (selection bias)	Unclear risk	Method of generating sequence not clearly described: "randomised block design with random length blocks.....incorporated a stratification scheme for age and cognitive impairment"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	All study team members, patient and physician blinded to allocation
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Delirium assessments conducted by trained research nurse blinded to allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat analysis performed. No withdrawals.
Selective reporting (reporting bias)	Unclear risk	Protocol for the study approved by John Hopkins Medicine Institutional Review Board but this is not publicly available
Other bias	Low risk	No evidence of other bias