Moretti 2003.
Methods | Design: randomized controlled trial Withdrawals: 2 Setting: single centre USA Sample size: 90 |
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Participants | Age (mean): buffered (Hextend) arm 59, non‐buffered arm (Hespan) 58 Gender (M/F): not described ASA grade: I to III Surgery type: major elective general, gynaecological, orthopaedic, or urological with anticipated blood loss > 500 mL Surgery duration (mean): 4.6/4.8 hours Anaesthesia type: general |
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Interventions | Three arms, only 2 of which are included 30 participants were enrolled into the buffered (Hextend) arm, and 30 into the non‐buffered arm (Hespan). Trial fluids were given according to a protocol, to ensure adequate volume during the operation. In addition, each arm was given a maintenance dose of lactated Ringer's solution (a buffered fluid). |
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Outcomes | Postoperative nausea and vomiting, oedema up to 24 hours after surgery | |
Notes | These are the same participant data as in Martin 2002, but different outcomes are reported. Funding source: supported in part by a grant from BioTime, Inc. Declarations of interest: none disclosed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded to participants, trial conductors and assessors |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Independent research personnel unaware of participant's collected randomization data |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant from each group did not proceed with fluid allocation. |
Selective reporting (reporting bias) | Low risk | No evidence of selection bias. All proposed outcome measures adequately reported |
Other bias | Unclear risk | One participant in each group fell out ‐ 1 did not need study fluid, and the other had surgery rescheduled. Analysis was completed on an intention‐to‐treat basis. Study was funded in part by BioTime Inc., which manufactures Hextend. |