Clinical Trial: Incidence and Severity of Residual Neuromuscular Blockade

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Incidence and Severity of Residual Neuromuscular Blockade With Application of a Protocol for Paralysis and Neostigmine Reversal of Rocuronium

Brief Summary: This prospective study will take place at Harborview Medical Center (HMC) and the University of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal surgery. The purpose of this study is to identify if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia with muscle relaxation in a population of patients undergoing abdominal surgery.

Detailed Summary:

80 patients will be enrolled in this prospective study. The first 40 patients will serve as controls and will not have an intervention.

Patients who have surgery and receive general anesthesia often receive muscle relaxants called neuromuscular blocking drugs or NMBDs. NMBDs facilitate anesthesiologists' performance of tracheal intubation, provide muscle relaxation during surgery, and are sometimes administered to prevent movement. After surgery, an anesthesiologist monitors how the muscle relaxants wear off, and gives a drug to help reverse the effect of the NMBDs before the tracheal breathing tube is removed and a patient is awakened and taken to the postoperative care area (PACU).

A patient who receives NMBDs for their routine care can experience a leftover effect of the drug after their general anesthesia wears off. This condition is called Residual Neuromuscular Blockade. The management of NMBDs in patients for routine care vary by anesthesia provider. This study will explore if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia. Anesthesiologists routinely use peripheral nerve stimulators to assess the degree of muscle relaxation. Very commonly a series of 4 electrical stimulations are given over 2 seconds and each stimulation result in a twitch of the thumb when the ulnar nerve is stimulated at the wrist. This is called train-of-four (TOF) monitoring. When the patient is deeply relaxed, then all twitches are not present but as the drug effect diminishes over time, the twitches return. When 4 twitches are present, an exact measurement of the so-called TOF ratio can be calculated if an objective monitor is used. The ratio is the strength of the fourth twitch divided by the strength of the first twitch. The most commonly used reversal drug is
Sponsor: University of Washington

Current Primary Outcome: Incidence of residual paralysis [ Time Frame: The outcome measure will be assessed at time of extubation ]

The incidence of residual paralysis defined as a TOF ratio <0.9 will be measured.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of severe residual paralysis [ Time Frame: The outcome measure will be assessed at time of extubation ]

The incidence of severe residual paralysis defined as a TOF ratio <0.7 will be measured.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: January 15, 2016
Date Started: January 2016
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016