Profound Muscle RelaxationPhase 4NCT01804933
Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function
A Phase 4 study testing profound neuromuscular blockade in people with Profound Muscle Relaxation and Muscle Trauma, run by Ying Xiao at 1 site in China.
Trial summary
Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many anesthesiologists,in fear of residual… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Profound Muscle Relaxation, Muscle Trauma, Postoperative Analgesic Demand
- What is being tested?
- profound neuromuscular blockade
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Aug 2013
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1~2,scheduled to undergo upper abdominal surgery by midline incision
Who cannot join
- neuromuscular disorder
- history of malignant hyperthemia
- allergy to medications used during general anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Ying Xiao, MD,PhD
About this study
Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative administration of muscle relaxants had to be minimized in spite of poor surgical conditions.
This study, however, is designed to test the hypothesis that profound neuromusclular blockade reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative analgesic requirement.On the other hand,profound muscle relaxation can decrease postoperative diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative pulmonary function.
- Conditions
- Profound Muscle Relaxation, Muscle Trauma, Postoperative Analgesic Demand, Postoperative Pulmonary Function
- Being tested
- profound neuromuscular blockade
- Keywords
- profound muscle relaxation, muscle trauma, postoperative analgesic demand, postoperative pulmonary function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
profound neuromuscular blockadeDrug
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| conventional neuromuscular blockade | No intervention | No rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement |
| optimal neuromuscular blockade | Active comparator | Rocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively Receives: Drug: profound neuromuscular blockade |
| profound neuromuscular blockade | Experimental | Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively Receives: Drug: profound neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of muscle trauma
serum CK
Measured: 72h postoperatively
Secondary outcomes (1)
postoperative analgesic requirement
consumption of morphine
Measured: 7days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Profound Muscle RelaxationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Xiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying Xiao, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ying Xiao, MD, PhD, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804933
- Sponsor's protocol ID
- 伦审[2012]326号
- Status last verified
- Mar 2013
- First submitted
- 4 Mar 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function
- ClinicalTrials.gov ID
- NCT01804933
- Acronym / sponsor ID
- 伦审[2012]326号
- Conditions
- Profound Muscle Relaxation, Muscle Trauma, Postoperative Analgesic Demand, Postoperative Pulmonary Function
- Keywords
- profound muscle relaxation, muscle trauma, postoperative analgesic demand, postoperative pulmonary function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ying XiaoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 5 Mar 2013 (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.
Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative administration of muscle relaxants had to be minimized in spite of poor surgical conditions.
This study, however, is designed to test the hypothesis that profound neuromusclular blockade reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative analgesic requirement.On the other hand,profound muscle relaxation can decrease postoperative diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative pulmonary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional neuromuscular blockade | No intervention | –No rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement |
| optimal neuromuscular blockade | Active comparator | Drug: profound neuromuscular blockadeRocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively |
| profound neuromuscular blockade | Experimental | Drug: profound neuromuscular blockadeRocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1~2,scheduled to undergo upper abdominal surgery by midline incision
Key exclusion criteria (3 listed)
- neuromuscular disorder
- history of malignant hyperthemia
- allergy to medications used during general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| profound neuromuscular blockadeRocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively | Drug | optimal neuromuscular blockade, profound neuromuscular blockade |
Primary outcome
degree of muscle trauma
Time frame: 72h postoperatively
serum CK
1 secondary outcome
postoperative analgesic requirement
Time frame: 7days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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.
Ying Xiao, MD, PhD study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing profound neuromuscular blockade in people with Profound Muscle Relaxation and Muscle Trauma, run by Ying Xiao at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2013. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Xiao, MD,PhD (13570521662, xying2603@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of muscle trauma (time frame: 72h postoperatively). 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 5 Mar 2013.