Skip to main content
OpenTrials
Completed

NCT Number: NCT02909439

Quality of Recovery After Reversal 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Sugammadex will be given for reversal of neuromuscular blockade.

Other names: Bridion

Neostigmine

Drug

Neostigmine will be given for reversal of neuromuscular blockade.

Other names: Prostigmine

Primary outcomes

  1. Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes

    Time frame: 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.

  2. Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes

    Time frame: 60 Minutes after reversal

    Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

  3. Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes

    Time frame: 120 minutes after reversal

    Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

Secondary outcomes

  1. Grip Strength, Change From Baseline and Recovery Profile 30 Min

    Time frame: 30 minutes

    Grip strength will be measured with a hand dynamometer

  2. Grip Strength, Change From Baseline and Recovery Profile 60 Min

    Time frame: 60 minutes after reversal

    Grip strength will be measured with a hand dynamometer

  3. Grip Strength, Change From Baseline and Recovery Profile 120 Min

    Time frame: 120 minutes after surgery

    Grip strength will be measured with a hand dynamometer

  4. Time to Extubation

    Time frame: Immediately after surgery, up to 30 minutes

    Measured time between surgery end and time of extubation (removal of breathing tube)

  5. Train of Four Ratio > 90% During PACU Admission

    Time frame: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.

    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%.

  6. Quality of Recovery 15 Survey

    Time frame: Postoperative day number one

    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.

  7. Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)

    Time frame: Within 4 hours from the end of surgery

    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.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 21, 2016
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.