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A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients

NCT ID: NCT01761552

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 \& 4E patients

Primary endpoint:

• Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.

Secondary endpoints:

• Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)

Detailed Description

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Conditions

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Neuromuscular Blockade

Keywords

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in ASA 4 AND ASA 4E patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sugammadex (tradename Bridion)

Group Type EXPERIMENTAL

Sugammadex Reversal

Intervention Type DRUG

Traditional reversal or spontaneous recovery:

Atropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip. Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade.

Group Type ACTIVE_COMPARATOR

Atropine/Neostigmine

Intervention Type DRUG

Interventions

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Sugammadex Reversal

Intervention Type DRUG

Atropine/Neostigmine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA 4 AND ASA 4E patients
* Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -

Exclusion Criteria

* Patients ASA 1-3 or 5
* Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
* Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
* Hypersensitivity to the active substances or to any of the excipients of medications used
* Patients with severe renal impairment (including patients requiring dialysis (CrCl \< 30mL/min))
* Patients with severe hepatic impairment
* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoram G Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hadas Lemberg, PhD

Role: CONTACT

Phone: 00 972 2 6777572

Email: [email protected]

Other Identifiers

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0513-12-HMO

Identifier Type: -

Identifier Source: org_study_id