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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01453530
First received: October 13, 2011
Last updated: October 17, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Anesthesia Recovery Period
Drug: Sugammadex
Drug: Neostigmine/Glycopyrrolate
Other: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Street Fitness in surgical patients undergoing general anesthesia after reversal of neuromuscular rest blockade. [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
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
Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453530

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

Locations
Netherlands
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
Investigators
Principal Investigator: Gert J. Scheffer, MD PhD Professor of Anesthesiology, UMC Radboud
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01453530     History of Changes
Other Study ID Numbers: 35385.091.11
Study First Received: October 13, 2011
Last Updated: October 17, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Recovery
Street fitness
Sugammadex
Alertness
Ambulatory surgery

Additional relevant MeSH terms:
Anesthetics
Glycopyrrolate
Neostigmine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014