Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04619225 - Cardiac Output and Recovery Time N/A
Recruiting NCT05992090 - Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography.
Completed NCT03585400 - Validation of the REPS Prediction Tool
Terminated NCT01678625 - Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade
Completed NCT03417804 - Incidence of Postoperative Residual Neuromuscular Blockade in Portugal
Completed NCT03111082 - Incidence of Postoperative Neuromuscular Blockade in Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?
Completed NCT04244266 - Observational Study in Bariatric Surgery
Completed NCT02939911 - Residual Neuromuscular Blockade in Pediatric Anesthesia
Completed NCT02660398 - Incidence and Severity of Residual Neuromuscular Blockade Phase 4
Completed NCT03920670 - Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit N/A
Completed NCT01837498 - Reversal of Neuromuscular Blockade in Thoracic Surgical Patients
Completed NCT02213848 - Effect of Calcium Chloride on Recovery From Neuromuscular Blockade N/A
Completed NCT04352140 - Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting N/A
Completed NCT04352127 - Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve N/A
Completed NCT04312256 - Thumb vs Great Toe Recovery N/A
Withdrawn NCT03574337 - Residual Neuromuscular Blockade in Cardiac Surgery Patients Phase 4