Reversal of rocuronium with neostigmine or sugammadex in high risk elderly patients: prospective randomized investigation of postoperative outcome
A randomised controlled trial evaluating the effects of neostigmine vs. sugammadex-based reversal of rocuronium on postoperative morbidity and mortality in high risk elderly patients
Thomas Ledowski
180 participants
May 9, 2014
Interventional
Conditions
Summary
Though neuromuscular paralysis with e.g. rocuronium is a frequent requirement to facilitate airway manipulation and surgery, there is a well known danger arising from the unpredictably duration of effect of these drugs (neuromuscular blocking agents, NMBA): residual neuromuscular blockade (RNMB). The incidence of RNMB is very high and ranges from 3.5-83%. RNMB affects patients’ postoperative wellbeing, but even more importantly respiratory function and hypoxic ventilator response. Patients with RNMB have been shown to suffer more adverse respiratory effects in the recovery room and during their stay in hospital with the obvious burden of disease to the individual but also a significant financial burden to the healthcare system. To avoid the above, patients in whom NMBA have been used are frequently “reversed” at the end of surgery. This means that the effects of the NMBA are antagonized with the cholinesterase-inhibitor neostigmine. A more recent method of reversal with significantly less side effects is the reversal of NMBA with sugammadex, a modified gamma-cyclodextrin which encapsulates the NMBA molecule prior to its renal excretion. Though sugammadex reversal is known to be faster and produce fewer side effects than neostigmine, no prospective investigation has so far shown different effects on postoperative outcome. However, a recent retrospective investigation involving 1444 patients showed a significant benefit for pulmonary outcome in high risk elderly patients when reversed with sugammadex vs neostigmine. Aim of this trial is to investigate the postoperative outcome of 180 high risk patients after reversal with either neostigmine or sugammadex.
Eligibility
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Interventions
Once all inclusion criteria have been fulfilled and all exclusion criteria have been excluded, a dedicated research assistant with no further data collection duties will access the randomisation website in order to randomize the patient to either: Sugammadex 2mg/k (intervention group) or: Neostigmine 0.05 mg/kg + atropine 0.015 mg/kg Theatre Patients will then proceed to have surgery and should at least receive rocuronium 0.6 mg/kg on induction of anaesthesia. Further doses of rocuronium (5-20 mg) will be administered if required to maintain a train of four (TOF) count of 1-2 twitches until the end of surgery. Both total intravenous or volatile based anaesthetic techniques may be used. Opioids used may be fentanyl, remifentanil, alfentanil, sufentanil, morphine and hydromorphone. TOF monitoring: in-theatre monitoring may be quantitative (preferred!) or qualitative (simple nerve stimulator). TOF is monitored intra-operatively at least every 5 min in order to maintain a TOF count of 1-2 (max!). At the end of the operation, at discretion of the attending anaesthetist the study reversal drug (anaesthetist blinded) is administered intravenously over 10 seconds and the time of administration noted. Subsequent TOF monitoring is not compulsory and fully at the discretion of the attending anaesthetist. 30 min prior to extubation all patients receive 4 mg ondansetron intravenously as antiemetic prophylaxis. After extubation the patient is transferred to the postoperative acute care unit (PACU) (or a high dependency area of similar quality, i.e.: intensive care unit or high dependency unit) where 6 l oxygen will be applied via a Hudson face mask.
Locations(4)
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ACTRN12614000108617