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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02146859
Other study ID # Si123
Secondary ID
Status Completed
Phase
First received May 16, 2014
Last updated March 24, 2018
Start date May 2014
Est. completion date March 2017

Study information

Verified date March 2018
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

study about residual neuromuscular blockade


Recruitment information / eligibility

Status Completed
Enrollment 222
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- - 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)

Exclusion Criteria:

- - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Faculty of medicine Siriraj hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary residual neuromuscular blockade after surgery residual neuromuscular blockade after surgery measure by train of four of nervestimulator 1 hour
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