Clinical trial NCT02909439: Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Official title: Pulmonary Function, Muscle Strength, Time to Extubation and Quality of Recovery in the Post Anesthesia Care Unit After Reversal of Neuromuscular Blockade With Neostigmine or Sugammadex.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Incomplete Reversal of Neuromuscular Block
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
timeFrame: 30 Minutes
measure: Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes
timeFrame: 60 Minutes after reversal
measure: Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes
timeFrame: 120 minutes after reversal
Secondary outcomes:
measure: Grip Strength, Change From Baseline and Recovery Profile 30 Min
timeFrame: 30 minutes
measure: Grip Strength, Change From Baseline and Recovery Profile 60 Min
timeFrame: 60 minutes after reversal
measure: Grip Strength, Change From Baseline and Recovery Profile 120 Min
timeFrame: 120 minutes after surgery
measure: Time to Extubation
timeFrame: Immediately after surgery, up to 30 minutes
measure: Train of Four Ratio > 90% During PACU Admission
timeFrame: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
measure: Quality of Recovery 15 Survey
timeFrame: Postoperative day number one
measure: Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)
timeFrame: Within 4 hours from the end of surgery
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook Medicine, Department of Anesthesiology
name: Ramon Abola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.
citation: Farhan H, Moreno-Duarte I, McLean D, Eikermann M. Residual Paralysis: Does it Influence Outcome After Ambulatory Surgery? Curr Anesthesiol Rep. 2014 Dec;4(4):290-302. doi: 10.1007/s40140-014-0073-6.
citation: Abola RE, Romeiser J, Rizwan S, Lung B, Gupta R, Bennett-Guerrero E. A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength. Can J Anaesth. 2020 Aug;67(8):959-969. doi: 10.1007/s12630-020-01695-4. Epub 2020 May 13.