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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

NCT01761552 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2013-09-10

No results posted yet for this study

Summary

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.)

Conditions

  • Neuromuscular Blockade

Interventions

DRUG

Sugammadex Reversal

DRUG

Atropine/Neostigmine

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Yoram G Weiss, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01761552 on ClinicalTrials.gov