Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis

NCT01503840 | Completed

• 1 other identifier: INT-66/11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization). This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%. The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.

Conditions

Postoperative Residual Paralysis

Outcome Measures

Primary Outcomes (4)

• Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex

  10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)

  10 minutes after surgery and 5 minutes later

• Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex

  10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)

  10 minutes after surgery and 5 minutes later

• Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex

  10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)

  10 minutes after surgery and 5 minutes later

• Forced Vital Capacity (FVC) changes after placebo or sugammadex

  10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)

  10 minutes after surgery and 5 minutes later

Secondary Outcomes (3)

• Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex

  10 minutes after surgery and 5 minutes later

• Hemogasanalysis parameters changes after placebo or sugammadex

  10 minutes after surgery and 5 minutes later

• Swallow ability changes after placebo or sugammadex

  10 minutes after surgery and 5 minutes later

Study Arms (2)

Sugammadex

ACTIVE COMPARATOR

Drug: sugammadex

Sodium chloride solution

PLACEBO COMPARATOR

Drug: Sodium chloride solution

Interventions

sugammadex DRUG

sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)

Also known as: Bridion

Sugammadex

Sodium chloride solution DRUG

Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.

Sodium chloride solution

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing major abdominal surgery
• age between 18 and 70 years
• ASA class 1 or 2
• patients scheduled for blended anesthesia (epidural + general anesthesia)
• patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).

You may not qualify if:

• known or suspected respiratory, cardiovascular or neuromuscular disease
• renal or hepatic failure
• known or suspected allergies to drugs used in the study
• risk for malignant hyperthermia
• pregnancy
• diagnosed depressive disorder

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Related Publications (1)

• Piccioni F, Mariani L, Bogno L, Rivetti I, Tramontano GT, Carbonara M, Ammatuna M, Langer M. An acceleromyographic train-of-four ratio of 1.0 reliably excludes respiratory muscle weakness after major abdominal surgery: a randomized double-blind study. Can J Anaesth. 2014 Jul;61(7):641-9. doi: 10.1007/s12630-014-0160-7. Epub 2014 Apr 17.

  PMID: 24740312 RESULT

MeSH Terms

Interventions

Sugammadex; Sodium Chloride

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Federico Piccioni, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori - Milan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 4, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

IT (1)