Georgiou 2013.
| Methods |
Study design: randomized controlled trial Sample size calculation: no information available |
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| Participants |
Number of randomized participants: 57 Inclusion criteria: super‐obese (SO) (BMI > 50 kg/m2) scheduled for open bariatric surgery Exclusion criteria: cardiovascular disease (NYHA > 2); refusal to participate in the study; contraindication to epidural catheter placement (e.g. anticoagulation, anti‐platelet medication); coexisting neuromuscular disease; history of allergic reaction to neuromuscular blocking agents; history of difficult intubation; creatinine levels > 159 mmol/L |
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| Interventions |
Anaesthesia: propofol and remifentanil NMBA: single intubating dose: rocuronium, dose not available; maintenance dose: not specified Comparison: sugammadex 2 mg/kg ideal body weight (n = 15) vs sugammadex 2 mg/kg corrected body weight (n = 13) vs neostigmine 50 µg/kg ideal body weight (n = 14) vs neostigmine 50 µg/kg corrected body weight (n = 15) Administration time of sugammadex or neostigmine or placebo: reappearance of T2 |
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| Outcomes |
Primary endpoint: full decurarization Secondary endpoint: ability to get into bed independently on arrival to the PACU and clinical signs of residual paralysis |
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| Notes |
Publication type: meeting abstract Country: Greece Conversions: recovery time to TOFR > 0.9, Mean + SD, from seconds to minutes Authors’ conclusions: Although transfer times to wards in neostigmine groups were ˜ 53 minutes longer than those in sugammadex groups, the cost of Sugammadex was > 400 times higher than the cost of neostigmine. Under current economic crisis conditions, one should take this seriously into consideration Contact: first trial author P. Georgiou contacted by email: prgeorg@yahoo.gr: 09.10.2015; no reply received |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly assigned"; no further information |
| Allocation concealment (selection bias) | Unclear risk | Unable to assess owing to insufficient information |
| Blinding of participants (performance bias) | Low risk | Participants blinded |
| Blinding of personnel (performance bias) | Unclear risk | Investigator blinded; no further information available |
| Blinding of primary outcome assessment (detection bias) | Unclear risk | Investigator blinded; no further information available |
| Blinding of safety assessment (detection bias) | Unclear risk | Investigator blinded; no further information available |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Low risk | Study protocol is available on clinicaltrials.gov (NCT01629394), and all of the study's prespecified outcomes of interest to the review have been reported in the prespecified way |
| Funding bias | Low risk | University of Patras |
| Other bias | Unclear risk | Unable to assess owing to insufficient information |