Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade
Status:
Unknown status
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
Rationale: Recovery from outpatient anesthesia includes dissipation of anesthetics agents,
normalization of physiological function, observation for medical or surgical complications,
treatment of immediate side effects of anesthesia and surgery and, ultimately, discharge and
return home. Street fitness implies that the patient is not only ready to go home, but is
also capable of safely taking part in the traffic. A full recovery of cognitive functions is
part of this stage. Neuromuscular blocking agents (NMBAs) are commonly used during surgery to
facilitate endotracheal intubation, allow assisted or controlled ventilation, and let surgery
proceed easily. Sugammadex is approved in Europe for routine clinical use to reverse
neuromuscular blockade induced by steroidal non-depolarizing muscle relaxants. Several
anesthesiologists from all over the world, have independently reported that patients seem to
be more alert in the early phase of recovery after reversal of NMB with sugammadex compared
to reversal with a cholinesterase inhibitor or spontaneous recovery. However, these
observations have not been substantiated in a clinical study.
Objective: The main aim of the present study is to assess whether sugammadex has a positive
effect on the post-operative alertness of the patients, to assess the nature, magnitude and
the time of onset of this effect and if a clinically relevant effect has been observed to
enable the sample size calculation for a formal well-powered efficacy study.
Study design: Randomized, controlled observer-blind single centre phase IV study. Upon After
stratification for type of surgery and age patients will be randomized to receive sugammadex
(arm A), neostigmine/glycopyrrolate (Arm B) or no reversal agent (arm C).
Study population: A total of 30 evaluable subjects, aged 18-65 years, with a medical need for
general anesthesia and neuromuscular blockade, will be included in the study.
Intervention: Anesthesia will be standardized according to the usual protocol. At the end of
the surgery when TOF ratio is ~0,9, and approximately 70-80% of nicotine receptors are still
blocked by rocuronium, patients will receive either sugammadex, neostigmine plus
glycopyrrolate, or no reversal agent.
Main study parameters: At 30, 60, and 120 minutes after the TOF ratio of ~0,9 has been
reached, the following commonly used, and non-invasive cognitive evaluations/scoring lists
will be carried out in a subsequent order to assess recovery and psychomotor function:
Modified Aldrete Score, the trail making test, the Maddox wing test, and visual analogue
scales from both observer and patient.