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. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

Nishikawa 2007.

Study characteristics
Methods RCT
Participants 54 women
Inclusion criteria: ASA I‐II status women, between 20 to 40 years, undergoing elective caesarean
Exclusion criteria: women with BMI > 30 kg/m², anaemia (Hb < 10 g/dL), history of neurological or psychiatric diseases
Setting: Japan
Interventions Colloid preload versus colloid coload versus crystalloid alone
Group 1: colloid preload: after Ringer's lactate was started at a rate of 5 mL/kg, this was changed to HES 6% (molecular weight 70 kDa, degree of substitution 0.5) and infusion rate was increased to 15 mL/kg for 10 min before spinal anaesthesia. Infusion rate was returned to Ringer's lactate at 5 mL/kg
Group 2: colloid coload: after Ringer's lactate was started at a rate of 5 mL/kg, this was changed to HES 6% (molecular weight 70 kDa, degree of substitution 0.5) and infusion rate was increased to 15 mL/kg for 10 min after spinal anaesthesia. Infusion rate was returned to Ringer's lactate at 5 mL/kg
Group 3: crystalloid alone: Ringer's lactate at 5 mL/kg
All women received standardised leg wrapping, no sedative premedication, and a standardised spinal anaesthetic technique and dose.
Hypotension requiring intervention was managed with IV bolus of 4 mg of ephedrine to maintain BP at 80% of baseline.
Bradycardia was managed with IV atropine 0.5 mg.
Outcomes Maternal: hypotension; need for ephedrine; BP; bradycardia
Neonatal: pH, BE, Apgar scores
Notes Hypotension was defined as a decrease in SBP < 80% baseline
Bradycardia was defined as heart rate < 50 bpm
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number tables
Allocation concealment (selection bias) Unclear risk No method of allocation concealment reported
Blinding of participants and personnel (performance bias)
All outcomes Low risk "Double‐blind"; "both the patient and the researcher who recorded the data were blinded as to the type of colloid loading"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias)
All outcomes Low risk No losses to follow‐up
Selective reporting (reporting bias) Low risk Most expected outcomes were reported (except for nausea/vomiting)
Other bias Unclear risk Similar baseline characteristics except that women in the HES coload group had lower mean BMI