Clinical Trial: Recovery of Muscle Function After Deep Neuromuscular Block by Means of Diaphragm Ultrasonography
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Recovery of Muscle Function After Deep Neuromuscular Block by Means of Dia-phragm Ultrasonography and Adductor Pollicis Acceleromyography: Comparison of Neostigmine vs. Sugammadex as Reversal Drugs.
Brief Summary: Diaphragm ultrasonography as a diagnostic tool in order to demonstrate the superiority of Sugammadex vs. AChEI in facilitating post-operative neuromuscular recovery.
Detailed Summary:
The proposed study will be a prospective, double-blind, single center randomized study performed in 60 patients with ASA physical status I-II, between 18-80 years old, undergoing dNMB with rocuronium during ear nose and throat (ENT) surgery. Randomization will be performed using a table created from the website www.randomization.com, and patients will be divided equally into two groups: Treatment with Sugammadex (SUG group) or treatment with Neostigmine (NEO group). Exclusion criteria will include: A history of hepatic or renal disease, chron-ic or acute alcoholism, allergy or hypersensitivity to Sugammadex and/or atropine or Neostigmine, current medications with CNS effects, a history of neurologic disease, diaphragmatic palsy, pregnancy or nursing arrhythmias. Continuous neuromuscular monitoring will be performed using TOF ratios obtained from ad-ductor pollicis muscle. At the conclusion of the surgical procedure, patients will receive either Neostigmine (NEO group) or Sugammadex (SUG group) for NMB reversal. The physician who will administer the study drugs will insure that is per-formed on an open-label (non-blinded) basis. All patients showing a TOF ratio ≥0.9 will be extubated. Diaphragmatic function (assessed by ultrasonographic evaluation of the TF and amplitude of excursion) will be evaluated in each subject at the following time points:
- Prior to induction of general anesthesia.
- At the conclusion of the surgical procedure when TOF ratio is 0.9.
- 15 and 30 minutes after discharge from the operating theatre. The physician who will perform the ultrasound scan will be different from the one who involved with administration of the drug for NMB reversal and the former will be blinded with respect to treatment received by patients. It is likely that, despite a TOF
Sponsor: University of Florence
Current Primary Outcome: Number of participants with post-operative residual curarization (PORC) as assessed by diaphragm ultrasonography in order to determine its muscle strenght [ Time Frame: 30 minutes from the end of surgical procedure ]
The clinician will assess TF (defined as a percentage) and amplitude of excursion (expressed in millimetres) of the diaphragm by means of ultrasonography
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants with post-operative complications related to PORC such as pneumonia as assessed chest x ray, drop of SpO2 by means of pulse oximeter and blood gas sample. [ Time Frame: up to 1 week ]
- Number of participants with post-operative nausea and vomiting (PONV) as assessed by postoperative nause and vomiting visual analogic scale (PONV VAS) [ Time Frame: up to 48 hours ]
Original Secondary Outcome: Same as current
Information By: University of Florence
Dates:
Date Received: February 15, 2016
Date Started: November 2014
Date Completion: July 2017
Last Updated: October 24, 2016
Last Verified: October 2016
