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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01761552

Enrollment

130

Registered

2013-01-04

Start date

2013-08-31

Completion date

Unknown

Last updated

2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

in ASA 4 AND ASA 4E patients

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.)

Interventions

DRUGSugammadex Reversal

DRUGAtropine/Neostigmine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.	24 hours

Secondary

Measure	Time frame
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

Measure	Time frame
The effect of Sugammadex on cortisol levels	72 hours

Countries

Israel

Contacts

Primary ContactHadas Lemberg, PhD

lhadas@hadassah.org.il00 972 2 6777572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026