Quality of Recovery After Reversal With Neostigmine or Sugammadex.

Stony Brook University

Status and phase: Completed; Phase 4

Conditions: Incomplete Reversal of Neuromuscular Block

Treatments: Drug: Neostigmine; Drug: Sugammadex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02909439

917402-3

Details and patient eligibility

About

This study will compare patient recovery measures after reversal of neuromuscular blockade with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle strength, time to extubation and quality of recovery in the post anesthesia care unit.

Full description

Sugammadex has been shown to have a faster onset and more reliable reversal of neuromuscular blockade when compared to neostigmine as measured by return of Train-of-four (TOF) ratio to >0.9. (Breuckmann, 2015) The investigator's hypothesis is that sugammadex will be associated with improved deep breathing as measured by incentive spirometry in the PACU. The investigators also hypothesize that patients reversed with sugammadex will have shorter times to extubation and better recovery profiles in the PACU as measured by strength, PACU discharge readiness and quality of recovery scores.

Residual neuromuscular blockade after surgery can result in airway compromise, pulmonary complications, and possible need for reintubation and can be a negative experience for patients. Reintubation after surgery is currently a quality measure in NSQIP (National Surgery Quality Improvement Program) A TOF ratio of <0.9 has been identified as a marker of residual neuromuscular blockade in the PACU. (Farhan 2013) Several clinical trials have shown that reversal of neuromuscular blockade with sugammadex results in a faster and more reliable return to TOF ratio of >0.9 when compared to neostigmine. However most of these studies primarily report on TOF ratios. There are scant data on clinical outcomes after reversal with neostigmine versus sugammadex. Incentive spirometry is a clinically meaningful measurement of postoperative pulmonary function, i.e the ability to breath deeply, which minimizes atelectasis and risk of postoperative pneumonia.

The investigators will compare recovery profiles of patients who have received sugammadex or neostigmine for reversal of neuromuscular blockade after surgery. The primary outcome will be incentive spirometry volumes after surgery as a measure of pulmonary function. The secondary measures include hand grip measured using a dynamometer, time to extubation, time to PACU discharge, time to sit independently, and quality of recovery 15 survey scores.

This will be a single-center, prospective, randomized, assessor blinded, controlled trial. Patients will be randomized to either receive sugammadex or neostigmine for the reversal of neuromuscular blockade. The anesthesiologist will be unblinded to the study drug however the assessor in the PACU will be blinded.

Enrollment: 80 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be willing and able to provide written informed consent for the study
• Participant must be greater than or equal to 18 years of age
• Participant must be ASA (American Society of Anesthesiologists) class I, II or III
• Planned use of neuromuscular blocking drugs
• Planned use of endotracheal intubation
• Planned for extubation to occur in the OR

Exclusion criteria

• ASA (American Society of Anesthesiologists) Class IV
• Age < 18 years old
• Inability to give oral or written consent
• Known or suspected neuromuscular disorder impairing neuromuscular function
• True allergy to muscle relaxants
• A (family) history of malignant hyperthermia
• A contraindication for neostigmine or sugammadex administration
• Serum creatinine level of greater than 2.0 mg/dL
• Surgery where the patient's arm is not available for neuromuscular monitoring
• A plan to extubate under deep anesthesia
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Neostigmine

Active Comparator group

Description:

Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.

Treatment:

Drug: Neostigmine

Sugammadex

Active Comparator group

Description:

Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.

Treatment:

Drug: Sugammadex