Martini 2014.
Methods |
Study design: randomized blinded study (BLISS trial) Sample size calculation: based on the expectation of the surgeon for distribution of surgical ratings between moderate and deep neuromuscular block |
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Participants |
Number of randomized participants: 26 Inclusion criteria: scheduled to undergo an elective laparoscopic prostatectomy or nephrectomy (partial or total) who have given written consent Exclusion criteria: ASA class > III, age < 18 years, inability to give informed consent, known or suspected neuromuscular disease, allergy to medication to be used during anaesthesia, (family) history of malignant hyperthermia, renal insufficiency (serum creatinine > 2 times normal, urine output < 0.5 mL/kg/h, glomerular filtration rate < 60 mL/h, or proteinuria), previous retroperitoneal surgery, body mass index ≥ 35 kg/m2 |
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Interventions |
Anaesthesia: propofol and sufentanil NMBA: single intubating dose: atracurium 0.5 mg/kg (for moderate NMB) or rocuronium 1.0 mg/kg (for deep NMB); maintenance dose: mivacurium 0.5 mg/kg/h (for moderate NMB) or rocuronium 0.6 mg/kg/h (for deep NMB) Comparison: neostigmine 1 to 2 mg + atropine 0.5 to 1 mg (for reversal of moderate NMB) (n = 12) vs sugammadex 4 mg/kg (for reversal of deep NMB) (n = 12) Administration time of neostigmine or sugammadex: reappearance of T2 or PTC 1 to 2 |
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Outcomes |
Primary endpoint: influence of the depth of NMB on the SRS (surgical rating score) Secondary endpoints: (1) assessment of the level of agreement between anaesthetists and surgeon in terms of their rating of surgical conditions, (2) effects of level of NMB on haemodynamic variables during surgery, time to TOFR.= 0.9, and relevant variables in the PACU (pain rating, sedation levels, and cardiorespiratory variables) |
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Notes |
Publication type: peer‐reviewed article Country: Netherlands Conversions: none Authors’ conclusions: Application of the 5‐point SRS showed that deep NMB results in improved quality of surgical conditions compared with moderate block in retroperitoneal laparoscopies, without compromise to patients’ perioperative and postoperative cardiorespiratory conditions Contact: first trial author A. Dahan contacted by e‐mail: a.dahan@lumc.nl on 27.05.2016; replied on 27.05.16 * Indicates unpublished data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was performed using a computer‐generated randomization code |
Allocation concealment (selection bias) | Unclear risk | Sealed, opaque, and sequentially numbered envelopes with codes were presented to the attending anaesthetist who prepared the medication and took care of participant dosing during anaesthesia * |
Blinding of participants (performance bias) | Low risk | Participants were under general anaesthesia and therefore were blinded |
Blinding of personnel (performance bias) | High risk | Attending anaesthesiologist was not blinded; the surgical team, the research team, and the anaesthetist who scored the video were all blinded |
Blinding of primary outcome assessment (detection bias) | Low risk | TOF measurements were performed by a fully blinded researcher or research nurse * |
Blinding of safety assessment (detection bias) | Low risk | PACU evaluation (pain, sedation, cardiovascular variables) was performed by a fully blinded researcher or research nurse * |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants are accounted for, and missing outcome data are balanced in numbers across intervention groups, with similar reasons for missing data across groups: A total of 30 patients were screened. Four patients met 1 or more exclusion criteria. The others were randomized. Two patients withdrew consent before treatment, resulting in 12 participants in each group |
Selective reporting (reporting bias) | Low risk | Study protocol is available on clinicaltrials.gov (NCT01631149), and all of the study’s prespecified outcomes of interest to the review have been reported in the prespecified way |
Funding bias | High risk | L.P.A. and A.D. received speaker fees from Merck BV, Oss, The Netherlands. This study is supported in part by Merck BV, Oss, The Netherlands, and by institutional funds from the Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands. Merck was not involved in the design and conduct of the study, data analysis, and production of the manuscript. Merck’s statistician Hein Fennema assisted with sample size analysis |
Other bias | High risk | Study sample size calculation not designed to address this review's primary or secondary outcomes. The 2 treatment groups were similar in physical characteristics, gender, types of surgery, and haemodynamic variables |