RecruitingPhase 4ACTRN12614000108617

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


Sponsor

Thomas Ledowski

Enrollment

180 participants

Start Date

May 9, 2014

Study Type

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

Sex: Both males and femalesMin Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two medicines used to reverse muscle paralysis caused by a drug called rocuronium (a muscle relaxant used during surgery). One reversal medicine is neostigmine (the standard treatment) and the other is sugammadex (a newer treatment). Researchers want to find out whether using sugammadex leads to better recovery — with fewer breathing problems — in elderly, high-risk surgical patients. You may be eligible if: - You are 75 years of age or older - You are having a planned or urgent (non-emergency) surgery - You are classified as ASA health risk category 3 or 4 (significant health conditions) - You received the muscle relaxant rocuronium during surgery - You are expected to be awake and breathing on your own at the end of surgery You may NOT be eligible if: - You are having emergency (immediate) surgery - You are unable to give consent - You had a significant lung infection or airway problem in the 7 days before surgery - You are planned to remain on a breathing machine after surgery - You are having heart or chest surgery, or have major chest injuries - You are allergic to any of the study drugs - You have a serious nerve or muscle disease - You have had a stroke with ongoing paralysis - You have an active serious infection (sepsis) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 websi

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)

Seoul, Korea, Republic Of

Groningen, Netherlands

Kuala Lumpur, Malaysia

Debrecen, Hungary

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ACTRN12614000108617