Ure 1999.
Study characteristics | ||
Methods | RCT | |
Participants | 50 women Inclusion criteria: singleton pregnancy, ASA I or II, presenting for elective caesarean at term Exclusion criteria: height < 152 cm, multiple pregnancy, pregnancy‐induced hypertension, placenta praevia, diabetes mellitus, maternal refusal, clotting disorder, fixed cardiac output disease, pre‐existing neurological disease, local and systemic sepsis, and allergy to local anaesthetics |
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Interventions |
Glycopyrrolate versus control Group 1: glycopyrrolate 200 µg Group 2: saline (placebo) All women received the study drug with a standardised crystalloid preload (15 mL/kg). All women received a standardised spinal anaesthetic technique and dose followed by standardised surgical positioning. |
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Outcomes |
Maternal: hypotension; nausea; nausea severity score; nausea episodes per woman; vomiting; ephedrine dose; heart rate; duration of operation; time to block; blood loss Neonatal: birthweight; Apgar score |
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Notes | Hypotension defined as decrease in SAP 20% or more from baseline or absolute decrease to less than 100 mmHg | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding: "double‐blind"; "both glycopyrrolate and saline were given as 1 mL of clear fluid and therefore the participant and researcher were blinded to the randomization" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: 1 woman in the glycopyrrolate group refused subarachnoid anaesthesia after the study drug had been given |
Selective reporting (reporting bias) | Low risk | Not apparent |
Other bias | Low risk | Not apparent |