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Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade (SFINX)

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ClinicalTrials.gov Identifier: NCT01453530
Recruitment Status : Unknown
Verified September 2011 by Radboud University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 18, 2011
Last Update Posted : October 18, 2011
Information provided by (Responsible Party):
Radboud University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Anesthesia Recovery Period Drug: Sugammadex Drug: Neostigmine/Glycopyrrolate Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Rest Blockade With Sugammadex
Study Start Date : October 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: Sugammadex
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.
Drug: Neostigmine/Glycopyrrolate
A single dose of neostigmine 0.04 mg/kg iv plus glycopyrrolate 0.01 mg/kg iv

Placebo Comparator: No reversal agent
No treatment
Other: Placebo

Primary Outcome Measures :
  1. Street Fitness in surgical patients undergoing general anesthesia after reversal of neuromuscular rest blockade. [ Time Frame: 120 minutes ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females.
  • Age 18-65 years.
  • Able to perform the study assessments.
  • ASA classification 1 or 2 (Appendix 1).
  • Medical need for general anesthesia and neuromuscular blockade.
  • NMB with the standard dose of rocuronium. If the surgery lasts longer than 75 minutes the patient will be excluded.
  • Minor surgical and gynecological procedures that require tracheal intubation and mechanical ventilation.
  • At the pre operative consult the patient will be asked if she is pregnant or if there is a possibility that she is pregnant. If yes, the patient will be excluded.
  • Signed informed consent.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Contra-indications for rocuronium, sugammadex, neostigmine and/or glycopyrrolate.
  • Use of toremifene, and/or fusidic acid from 24 hours before till 24 hours after surgery.
  • Patients on oral hormonal contraceptives: inability/unwillingness to comply with the instructions for a missed dose according to the SPC text after surgery.
  • Patients on non-oral hormonal contraceptives: inability/unwillingness to apply additional non-hormonal contraceptive methods during the 7 days after surgery.
  • Concomitant conditions or diseases that might interfere with the study assessments.
  • Concomitant treatment with any experimental drug within 4 weeks before surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453530

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Contact: Gert J. Scheffer, MD Phd (31) 024 3614553 G.Scheffer@anes.umcn.nl

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UMC Sint Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Diana M Peters-Gómez Valdez, MD       d.peters-gomezvaldez@anes.umcn.nl   
Principal Investigator: Gert J. Scheffer, MD PhD         
Sub-Investigator: Diana M. Peters-Gómez Valdez, MD         
Sponsors and Collaborators
Radboud University Medical Center
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Principal Investigator: Gert J. Scheffer, MD PhD Professor of Anesthesiology, UMC Radboud
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT01453530    
Other Study ID Numbers: 35385.091.11
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: September 2011
Keywords provided by Radboud University Medical Center:
Street fitness
Ambulatory surgery
Additional relevant MeSH terms:
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Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists