Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Milan, Italia
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Sugammadex
|
sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v.
(0,1 ml/kg)
Andre navn:
|
|
Placebo komparator: Sodium chloride solution
|
Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
Tidsramme: 10 minutes after surgery and 5 minutes later
|
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
Tidsramme: 10 minutes after surgery and 5 minutes later
|
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
Tidsramme: 10 minutes after surgery and 5 minutes later
|
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
Tidsramme: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
Tidsramme: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Hemogasanalysis parameters changes after placebo or sugammadex
Tidsramme: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Swallow ability changes after placebo or sugammadex
Tidsramme: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Federico Piccioni, MD, Fondazione IRCCS Istituto Nazionale dei tumori - Milan
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- INT-66/11
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