Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade (SFINX)
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.
Anesthesia Recovery Period
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
|Official Title:||Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Rest Blockade With Sugammadex|
- Street Fitness in surgical patients undergoing general anesthesia after reversal of neuromuscular rest blockade. [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Sugammadex
A single dose of sugammadex 2 mg/kg iv. Dose calculation will be based on the patient's actual body weight. No dose adjustments are allowed
A single dose of sugammadex 2 mg/kg iv
Other Name: Bridion
Active Comparator: Neostigmine/glycopyrrolate
A single dose of neostigmine 0.04 mg/kg iv plus glycopyrrolate 0.01 mg/kg iv. Dose calculation will be based on the patient's actual body weight. No dose adjustments are allowed.
A single dose of neostigmine 0.04 mg/kg iv plus glycopyrrolate 0.01 mg/kg iv
Placebo Comparator: No reversal agent
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|Contact: Gert J. Scheffer, MD Phd||(31) 024 3614553||G.Scheffer@anes.umcn.nl|
|UMC Sint Radboud||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Contact: Diana M Peters-Gómez Valdez, MD firstname.lastname@example.org|
|Principal Investigator: Gert J. Scheffer, MD PhD|
|Sub-Investigator: Diana M. Peters-Gómez Valdez, MD|
|Principal Investigator:||Gert J. Scheffer, MD PhD||Professor of Anesthesiology, UMC Radboud|