Skip to main content
. 2021 Jul 19;2021(7):CD013307. doi: 10.1002/14651858.CD013307.pub2

Fan 2014.

Study characteristics
Methods Design: RCT
Date of study: October 2011 to May 2013
Power calculation: no
Inclusion criteria: patients older than 65 years undergoing elective unilateral total hip replacement surgery with spinal anaesthetic
Exclusion criteria: ASA physical status 3 IV; preoperative delirium; unwilling to comply with the procedures; inability to understand the language (Mandarin Chinese); hearing loss, or a failure in spinal anaesthesia
Participants Sample size:192
Country: China
Setting: hospital inpatient – elective orthopaedics
Age: mean age 73 (+/‐ 7) in the intervention group, 75 (+/‐ 6) in the control group
Sex: male, 30, (31.9%) in the Intervention group, male, 32, (35.9%) in the control group
Co‐morbidity: no baseline between‐group differences in CVD, IHD, CHF, hypertension, pulmonary disease, renal insufficiency, PVD, diabetes mellitus, liver disease.
Dementia: not mentioned explicitly but cognitive assessment undertaken using MMSE
Frailty: not reported
Interventions Intervention: patients older than 65 years undergoing elective unilateral total hip replacement surgery with spinal anaesthetic.
Control: ASA physical status 3 IV; preoperative delirium; unwilling to comply with the procedures; inability to understand the language (Mandarin Chinese); hearing loss, or a failure in spinal anaesthesia
Outcomes Outcomes reported
‐ Incident delirium using the Confusion Assessment Method for the intensive care unit (CAM‐ICU)
‐ Length of stay
‐ Withdrawal
Outcomes from study not reported: none
Frequency of outcomes assessment: Delirium was assessed by the same attending anaesthesiologist between 8 a.m. and 9 a.m. preoperatively, and 1, 2, 3 days after surgery.
Notes Funding source: this work was supported by the grants from the National Natural Science Foundation of China (No. 81300946) and the Natural Science Foundation of Jiangsu Province (BK2012778).
Declarations of interest: no conflict of interest stated by authors
Delirium excluded at enrolment using the (CAM‐ ICU) criteria (Chinese version)
Imbalance between groups om other substances transfused – restrictive group received more Ringer’s lactate and hydroxyethyl starch 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned to restrictive or liberal group using a random number table
Allocation concealment (selection bias) Unclear risk The method used to was sealed envelope technique, however, there is insufficient detail as to whether these were opaque.
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding of participants or personnel described
Blinding of outcome assessment (detection bias)
All outcomes High risk No blinding of outcome assessments described
Incomplete outcome data (attrition bias)
All outcomes Low risk Clear accounting for all participants at follow‐up. Loss of 2 from restrictive and 4 from liberal transfusion groups at follow‐up due to declined consent for transfusion.
Selective reporting (reporting bias) Unclear risk Insufficient information to assess as no published protocol
Other bias Low risk No evidence of other bias