Residual Neuromuscular BlockadeNCT02146859
Predictor of Residual Neuromuscular Blockade in Recovery Room After General Anesthesia
An observational study of Residual Neuromuscular Blockade, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Neuromuscular Blockade
- How many people
- 222 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient who are schedule for general anesthesia and use neuromuscular blocking agents (NMBAs)
Who may be able to join
- - 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)
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
study about residual neuromuscular blockade
- Conditions
- Residual Neuromuscular Blockade
- Keywords
- residual neuromuscular blockade
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Patient having general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual neuromuscular blockade after surgery
residual neuromuscular blockade after surgery measure by train of four of nervestimulator
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaowanan Khamtuikrua, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146859
- Sponsor's protocol ID
- Si123
- Status last verified
- Mar 2018
- First submitted
- 16 May 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictor of Residual Neuromuscular Blockade in Recovery Room After General Anesthesia
- ClinicalTrials.gov ID
- NCT02146859
- Acronym / sponsor ID
- Si123
- Conditions
- Residual Neuromuscular Blockade
- Keywords
- residual neuromuscular blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
study about residual neuromuscular blockade
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | – | –Patient having general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who are schedule for general anesthesia and use neuromuscular blocking agents (NMBAs)
Key inclusion criteria (3 listed)
- - 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)
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
residual neuromuscular blockade after surgery
Time frame: 1 hour
residual neuromuscular blockade after surgery measure by train of four of nervestimulator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Residual Neuromuscular Blockade, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual neuromuscular blockade after surgery (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.