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

NCT01453530 | Unknown Phase 4 DMC

• 1 other identifier: 35385.091.11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Recovery Period

Keywords

Recovery; Street fitness; Sugammadex; Alertness; Ambulatory surgery

Outcome Measures

Primary Outcomes (1)

• Street Fitness in surgical patients undergoing general anesthesia after reversal of neuromuscular rest blockade.

  120 minutes

Study Arms (3)

Sugammadex

ACTIVE COMPARATOR

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

Neostigmine/glycopyrrolate

ACTIVE COMPARATOR

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

No reversal agent

PLACEBO COMPARATOR

No treatment

Other: Placebo

Interventions

Sugammadex DRUG

A single dose of sugammadex 2 mg/kg iv

Also known as: Bridion

Sugammadex

Neostigmine/Glycopyrrolate DRUG

A single dose of neostigmine 0.04 mg/kg iv plus glycopyrrolate 0.01 mg/kg iv

Neostigmine/glycopyrrolate

Placebo OTHER

Placebo

No reversal agent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

UMC Sint Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gert J. Scheffer, MD PhD

  Professor of Anesthesiology, UMC Radboud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gert J. Scheffer, MD Phd

CONTACT

(31) 024 3614553; G.Scheffer@anes.umcn.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 18, 2011

Record last verified: 2011-09

Locations

NL (1)