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 |
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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. |
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Outcomes |
Maternal: hypotension; need for ephedrine; BP; bradycardia Neonatal: pH, BE, Apgar scores |
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Notes | Hypotension was defined as a decrease in SBP < 80% baseline Bradycardia was defined as heart rate < 50 bpm |
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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 |