Ngan Kee 2013a.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 104 participants Inclusion criteria: ASA I‐II, age > 18 years, term singleton pregnancy, elective caesarean under spinal anaesthesia Exclusion criteria: pre‐existing or gestational hypertension, abnormality of fetus, onset of uterine contraction, coagulopathy, thrombocytopenia, cerebrovascular or cardiovascular disease, any contraindication to the use of spinal anaesthesia, height > 180 cm or < 140 cm, weight > 100 kg or < 50 kg Setting: Hong Kong, China |
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| Interventions |
Prophylactic glycopyrrolate versus control Group 1: single IV bolus of glycopyrrolate 4μg/kg diluted in saline to 2 mL administered at commencement of spinal injection Group 2: single IV bolus 2 mL saline placebo administered at commencement of spinal injection All women received standardised aspiration prophylaxis, standardised monitoring, standardised positioning, standardised cannulation, a standardised spinal anaesthetic technique and dose, and standardised crystalloid coload. BP maintained using infusion of phenylephrine 100 μg/mL using a computer controlled closed‐loop feedback infusion. |
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| Outcomes |
Maternal: total dose and median rate of phenylephrine infusion, total amount of IV fluid given, number of episodes of hypotension, nausea and vomiting Neonatal: Apgar scores, umbilical cord gases |
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| Notes | Hypotension was defined as SBP < 80% of baseline. Hypertension was defined as SBP > 120% of 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 | Computer‐generated random codes |
| Allocation concealment (selection bias) | Low risk | Sealed opaque sequentially numbered envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Yes, both blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Group 1 – 5 excluded due to severe shivering, infusion tubing fault, computer cable fault Group 2 – 6 excluded due to severe shivering, infusion tubing fault |
| Selective reporting (reporting bias) | Low risk | Appears all reported |
| Other bias | Low risk | None evident |