NCT02660398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

January 15, 2016

Last Update Submit

May 17, 2019

Conditions

Residual Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Incidence of residual paralysis

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

    The outcome measure will be assessed at time of extubation

Secondary Outcomes (1)

  • Incidence of severe residual paralysis

    The outcome measure will be assessed at time of extubation

Study Arms (2)

Controls

NO INTERVENTION

Our control group will consist of an observational cohort of 40 patients in whom we will make quantitative assessments of the Train-of-four ratio (TOF ratio). This is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU).

Intervention

OTHER

The intervention consists of a protocol for intraoperative management of neuromuscular blockade with rocuronium and reversal with neostigmine. A train-of-four count of 4 at the thumb will be confirmed prior to administration of an adjusted dose of neostigmine. TOF ratio is measured in the same manner as for the Control group, it is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU).

Procedure: Standardized NMBD Management

Interventions

Standardized NMBD ManagementPROCEDURE

The intervention phase will introduce a standardized research protocol that spells out NMBD management, including how muscle relaxant should be administered and monitored, and how reversal with neostigmine should be done.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 18 or older
  • Will undergo open or laparoscopic abdominal surgery expected to last \<6 hours at HMC or UWMC
  • Have ASA physical status I-III
  • Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for endotracheal intubation or maintenance of neuromuscular block (NMB)

You may not qualify if:

  • Allergy to NMBDs
  • Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)
  • Pregnant or lactating women
  • Non-English speaking
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Thilen SR, Ng IC, Cain KC, Treggiari MM, Bhananker SM. Management of rocuronium neuromuscular block using a protocol for qualitative monitoring and reversal with neostigmine. Br J Anaesth. 2018 Aug;121(2):367-377. doi: 10.1016/j.bja.2018.03.029. Epub 2018 May 19.

    PMID: 30032875DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephan Thilen, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Anesthesiology

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 21, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)