Quality of Recovery After Reversal With Neostigmine or Sugammadex.

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.

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.

Study Overview

• Status: Completed
• Conditions: Incomplete Reversal of Neuromuscular Block
• Intervention / Treatment: Drug: Neostigmine; Drug: Sugammadex

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neostigmine; Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.	Drug: Neostigmine; Neostigmine will be given for reversal of neuromuscular blockade.; Other Names: Prostigmine
Active Comparator: Sugammadex; Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.	Drug: Sugammadex; Sugammadex will be given for reversal of neuromuscular blockade.; Other Names: Bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes	Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.	30 Minutes
Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes	Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.	60 Minutes after reversal
Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes	Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.	120 minutes after reversal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength, Change From Baseline and Recovery Profile 30 Min	Grip strength will be measured with a hand dynamometer	30 minutes
Grip Strength, Change From Baseline and Recovery Profile 60 Min	Grip strength will be measured with a hand dynamometer	60 minutes after reversal
Grip Strength, Change From Baseline and Recovery Profile 120 Min	Grip strength will be measured with a hand dynamometer	120 minutes after surgery
Time to Extubation	Measured time between surgery end and time of extubation (removal of breathing tube)	Immediately after surgery, up to 30 minutes
Train of Four Ratio > 90% During PACU Admission	Train of four ratio (TOFR) is the ration of the twitch height of the 4th twitch compared to the 1st twitch during train of four neuromuscular stimulation. This measurement was performed using a TOF Watch, which in an accelemyographer. Electric current is applied to the ulnar nevre and the twitches are measured in the thumb. Adequate reversal of neuromuscular blockade is defined as a TOFR >90%.	At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
Quality of Recovery 15 Survey	15 question survey to assess patient's overall quality of recovery after anesthesia/surgery. Quality of Recovery 15 Survey. Minimum: 0 Maximum: 150 Higher Scores mean a better outcome and better quality of recovery. Part A: How have you been feeling in the last 24 hours? 0 = none of the time (poor), 10 = all of the time (excellent). Examples: able to breath easily, able to enjoy food, feeling rested. etc. Part B: Have you had any of the following in the last 24 hours? 10 to 0, where 10 = none of the time (Excellent) and 0 = all of the time (poor). Examples: moderate pain, nausea or vomiting, feeling worried or anxious, etc.	Postoperative day number one
Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)	Measured time between PACU admission and meeting PACU discharge readiness. PACU discharge was defined as when the patient had an Aldrete score of 9 or higher as determined by the PACU nurse. The Aldrete score is a measure of post anesthesia recovery. 0 is poor condition and 10 is excellent condition. There are 5 assessment items (able to move voluntary, breathing, consciousness, circulation (BP) and spO2) which are graded on a 0-2 point scale with 0 being poor and 2 being excellent.	Within 4 hours from the end of surgery

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Ramon Abola, MD, Stony Brook Medicine, Department of Anesthesiology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): November 9, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: 917402-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No