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

Neuromuscular Blockade Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01761552
• Other study ID #: 0513-12-HMO
• Status: Recruiting
• Phase: Phase 4
• First received: December 20, 2012
• Last updated: September 8, 2013
• Start date: August 2013

Study information

• Verified date: September 2012
• Source: Hadassah Medical Organization
• Contact: Hadas Lemberg, PhD
• Phone: 00 972 2 6777572
• Email: lhadas[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Sugammadex Reversal

• Atropine/Neostigmine

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effect of Sugammadex on cortisol levels		72 hours	Yes
Primary	Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.		24 hours	No
Secondary	Time to extubation - measure the difference in time from application of the surgical dressing until extubation.		24 hours	No
Secondary	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	No