Target Controlled Infusion (TCI)Phase 4NCT02135016
The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction
A Phase 4 study testing 1% lidocaine, 2% lidocaine and 0.9% normal saline in people with Target Controlled Infusion (TCI) and Thoracic Epidural Anesthesia, run by First Hospital of China Medical University at 1 site in China.
Trial summary
It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA with different block level on propofol concentration during general anesthesia induction. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Target Controlled Infusion (TCI), Thoracic Epidural Anesthesia, Block Level
- What is being tested?
- 1% lidocaine, 2% lidocaine and 0.9% normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I-II physical status,
- aged 40-60 yr,
- BMI 19-25 kg/m2,
- undergoing elective gastrointestinal surgery
Who cannot join
- patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Concentration During General Anesthesia Induction
It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA with different block level on propofol concentration during general anesthesia induction.
- Conditions
- Target Controlled Infusion (TCI), Thoracic Epidural Anesthesia, Block Level, Gastrointestinal Surgery
- Being tested
- 1% lidocaine, 2% lidocaine, 0.9% normal saline
- Keywords
- effect-site concentration, propofol, thoracic epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% lidocaineDrug
Also called A
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
2% lidocaineDrug
Also called B
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
0.9% normal salineDrug
Also called C
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
| Study group | Role | What they receive |
|---|---|---|
| 1% lidocaine | Experimental | epidural anesthesia with 1% lidocaine 10ml before propofol TCI Receives: Drug: 1% lidocaine |
| 2% lidocaine | Experimental | epidural anesthesia with 2% lidocaine 5ml before propofol TCI Receives: Drug: 2% lidocaine |
| 0.9% normal saline | Placebo comparator | epidural anesthesia with 0.9% normal saline 5ml before propofol TCI Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect-site Concentration of Propofol
The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
Measured: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
Secondary outcomes (4)
The Bispectral Index
The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).
Measured: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Mean Blood Pressure
The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
Measured: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Heart Rate
The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
Measured: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Block Level of Epidural Anesthesia
The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).
Measured: 20 mins after epidural anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Target Controlled Infusion (TCI)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, First Hospital of China Medical University
- Investigators
- Jun Wang, professor, Study director, Dept. of Anesthesiology, First Affiliated Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135016
- Sponsor's protocol ID
- 20140415
- Status last verified
- Aug 2014
- First submitted
- 30 Apr 2014
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Concentration During General Anesthesia Induction
- ClinicalTrials.gov ID
- NCT02135016
- Acronym / sponsor ID
- 20140415
- Conditions
- Target Controlled Infusion (TCI), Thoracic Epidural Anesthesia, Block Level, Gastrointestinal Surgery
- Keywords
- effect-site concentration, propofol, thoracic epidural anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA with different block level on propofol concentration during general anesthesia induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% lidocaine | Experimental | Drug: 1% lidocaineepidural anesthesia with 1% lidocaine 10ml before propofol TCI |
| 2% lidocaine | Experimental | Drug: 2% lidocaineepidural anesthesia with 2% lidocaine 5ml before propofol TCI |
| 0.9% normal saline | Placebo comparator | Drug: 0.9% normal salineepidural anesthesia with 0.9% normal saline 5ml before propofol TCI |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I-II physical status,
- aged 40-60 yr,
- BMI 19-25 kg/m2,
- undergoing elective gastrointestinal surgery
Key exclusion criteria (1 listed)
- patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.
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 |
|---|---|---|
| 1% lidocaineAlso: Aepidural anesthesia with 1% lidocaine 10ml before propofol TCI | Drug | 1% lidocaine |
| 2% lidocaineAlso: Bepidural anesthesia with 2% lidocaine 5ml before propofol TCI | Drug | 2% lidocaine |
| 0.9% normal salineAlso: Cepidural anesthesia with 0.9% normal saline 5ml before propofol TCI | Drug | 0.9% normal saline |
Primary outcome
The Effect-site Concentration of Propofol
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
4 secondary outcomes
The Bispectral Index
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Mean Blood Pressure
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Heart Rate
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Block Level of Epidural Anesthesia
Time frame: 20 mins after epidural anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jun Wang, professor study director
Dept. of Anesthesiology, First Affiliated Hospital of China Medical 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 1% lidocaine, 2% lidocaine and 0.9% normal saline in people with Target Controlled Infusion (TCI) and Thoracic Epidural Anesthesia, run by First Hospital of China Medical University 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 4 inclusion and 1 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 29 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Effect-site Concentration of Propofol (time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an 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 29 Aug 2014.