Castro 2014.
Methods |
Study design: prospective, controlled, randomized study Sample size calculation: no information available |
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Participants |
Number of randomized participants: 88 Inclusion criteria: morbidly obese (MO) and scheduled for laparoscopic bariatric surgery under general anaesthesia Exclusion criteria: lack of consent, followed in chronic pain consultation, already enrolled in another study conducted at our institution (pregabalin effect as preemptive analgesia for surgery in the obese), and previous LBS in the same patient |
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Interventions |
Anaesthesia: propofol 1.5 to 2.0 mg/kg CBW, analgesia maintained with remifentanil 0.15 to 0.30 mg/kg CBW, anaesthesia maintained with mixture of oxygen, air, and desflurane in vol % NMBA: no information available Comparison: sugammadex 2 mg/kg (n = 44) vs neostigmine 0.05 µg/kg + atropine 20 µg/kg (n = 44) Administration time of sugammadex or neostigmine: reappearance of T2 |
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Outcomes | Pain using the visual analogue scale at 4 different moments: arrival to PACU, 30 minutes after arrival, 60 minutes after arrival, and immediately before leaving PACU; presence of postoperative nausea and vomits (PONV); and duration of PACU stay before discharge to the ward | |
Notes |
Publication type: peer‐reviewed article Country: Portugal Conversions: none Handling of adverse events: No discrepancy exists between AEs presented in the original article and those reported in this review Authors’ conclusions: Sugammadex is associated with less pain in the PACU. This “opioid‐sparing” effect, combined with less PONV and faster discharge from the PACU, makes sugammadex an indispensable drug for this type of patient and allows fast‐track surgery in the MO Contact: first trial author Diogo S. Castro contacted by email: diogosousacastro@hotmail.com on 15.05.2016; no reply received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization was performed by the investigator using previously prepared envelopes |
Allocation concealment (selection bias) | Unclear risk | Randomization was performed by the investigator using previously prepared envelopes |
Blinding of participants (performance bias) | Unclear risk | Unable to assess owing to insufficient information |
Blinding of personnel (performance bias) | Unclear risk | Unable to assess owing to insufficient information |
Blinding of primary outcome assessment (detection bias) | Unclear risk | Unable to assess owing to insufficient information |
Blinding of safety assessment (detection bias) | Unclear risk | Unable to assess owing to insufficient information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data: 88 eligible participants were randomized into 2 groups of 44; no patients were excluded |
Selective reporting (reporting bias) | Low risk | Study protocol not available, but published article clearly includes all expected outcomes |
Funding bias | Unclear risk | Unable to assess owing to insufficient information |
Other bias | Unclear risk | No apparent other type of bias, except no information on sample size calculation. No differences in participant characteristics between groups |