Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2022-03-03

Brief Summary

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The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.

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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Neuromuscular blockade reversed with neostigmine/gly

Group Type EXPERIMENTAL

Neostigmine+glycopyrrolate

Intervention Type DRUG

At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate

Neuromuscular blockade reversed with sugammadex

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

At the conclusion of surgery neuromuscular blockade reversed with sugammadex

Interventions

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Neostigmine+glycopyrrolate

At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate

Intervention Type DRUG

Sugammadex

At the conclusion of surgery neuromuscular blockade reversed with sugammadex

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients age 18 years of age or greater who are capable of giving consent
* Undergoing surgical procedures of expected length 6 \</= hours requiring NMB

Exclusion Criteria

* Pregnancy
* History of documented anaphylaxis or contraindication to any of the study medications
* Active coronary disease with a positive cardiac stress test
* History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 \< 50% of predicted
* Serum Creatinine \>/= 2.0 mg/dL
* Severe hepatic dysfunction accompanied by coagulopathy

* Definition:
* Known liver Disease AND
* INR \> 1.5 (except for patients on anticoagulants) AND
* Platelet count \<100,00/ul without other obvious cause
* Chronic sustained release opioid for \> 2 weeks duration pre op (in the 30 days prior to surgery)
* Use of toremifene
* Significant cognitive impairment or documented psychologic impairment
* Myasthenia gravis or other neuromuscular disease
* Patients who are not eligible for standard anesthetic induction, eg, those needing rapid sequence induction or awake fiberoptic bronchial intubation.
* American Society of Anesthesiologists (ASA) Status \> 3

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No