NCT02146859

Brief Summary

Background When general anesthesia was performed, neuromuscular blocking agents (NMBAs) are frequently used for facilitate tracheal intubation and keep patient still and relax during surgery. Unfortunately, residual neuromuscular blockade are important complication. There are many factors that affect neuromuscular blockade and may prolong effect of NMBAs which we already know about that such as body temperature, drugs, some kind of diseases. However there are no recent studies that mention about other factors. The purpose of this study is to find out other factors that affect NMBAs effect to improve patient safety. Methods The study is a prospective, non-randomized, blinded, observational study. 222 patients will be included in this study and will be performed general anesthesia. Anesthetic technique and agent which are used depend on regular staff. Information of patient will be collected are age, sex, weight, height, ASA classification, anesthetic technique, anesthetic and surgical time, amount of inhalation agent, amount of NMBAs, amount of opioids and reversal agents. After anesthesia finish, patient will be brought to recovery room and Train Of Four watch® will be placed and record Train Of Four ratio by this research staff. Train Of Four ratio \< 0.9 will be defined as there is residual neuromuscular blockade in this patient. All patients will be divided into 2 groups: residual blockade group(patient who have train of four \<0.9 after surgery) and no residual blockade group(patient who have train of four \>0.9). All factor of each group will be compared between. Statistical will be analyzed to find significant factor which affect neuromuscular blockade.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

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

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.7 years

First QC Date

May 16, 2014

Last Update Submit

March 24, 2018

Conditions

Keywords

residual neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • residual neuromuscular blockade after surgery

    residual neuromuscular blockade after surgery measure by train of four of nervestimulator

    1 hour

Study Arms (1)

general anesthesia

Patient having general anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient who are schedule for general anesthesia and use neuromuscular blocking agents (NMBAs)

You may qualify if:

  • \- age ≥ 18 years
  • American society of anesthesiologist class I-III
  • patient who are schedule for intraabdominal surgery, orthopedic surgery and gynecologic surgery under general anesthesia and use neuromuscular blocking agents (NMBAs)

You may not qualify if:

  • \- patients who have myasthenia gravis, myotonia, muscular dystrophy, upper motor neuron lesion
  • patients who have drug which influence neuromuscular action such as oral muscle relaxant, anticonvulsants, magnesium sulfate
  • Body temperature \>37.8 or \< 36 degree Celsius before operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Siriraj hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 26, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations