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

Hadassah Medical Organization130 enrolled

Overview

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.)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Neuromuscular Blockade

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 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.)

Time frame: 24 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts