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 | Unknown Phase 4

• 1 other identifier: 0513-12-HMO
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

in ASA 4 AND ASA 4E patients

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Secondary Outcomes (2)

• Time to extubation - measure the difference in time from application of the surgical dressing until extubation.

  24 hours

• 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.)

  24 hours

Other Outcomes (1)

• The effect of Sugammadex on cortisol levels

  72 hours

Study Arms (2)

Sugammadex (tradename Bridion)

EXPERIMENTAL

Drug: Sugammadex Reversal

Traditional reversal or spontaneous recovery:

ACTIVE COMPARATOR

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.

Drug: Atropine/Neostigmine

Interventions

Sugammadex Reversal DRUG

Sugammadex (tradename Bridion)

Atropine/Neostigmine DRUG

Traditional reversal or spontaneous recovery:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Interventions

Atropine; Neostigmine

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Onium Compounds

Study Officials

• Yoram G Weiss, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572; lhadas@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 4, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: September 10, 2013

Record last verified: 2012-09

Locations

IL (1)