Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 11/10/2017 |
Start Date: | November 2016 |
End Date: | December 2017 |
Contact: | Sabeen Rizwan |
Email: | sabeen.rizwan@stonybrookmedicine.edu |
Phone: | 631-638-1214 |
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.
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.
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.
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.
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
We found this trial at
1
site
Stony Brook, New York 11794
Principal Investigator: Ramon Abola, MD
Phone: 631-638-1214
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