General AnesthesiaPhase 4NCT02000973
Effects of Epidural Local Anesthetics on Propofol Induction
A Phase 4 study testing Lidocaine, Bupivacaine and Ropivacaine in people with General Anesthesia and Propofol Target-controlled Infusion, run by First Hospital of China Medical University.
Trial summary
The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- General Anesthesia, Propofol Target-controlled Infusion, Thoracic Epidural Anesthesia
- What is being tested?
- Lidocaine, Bupivacaine and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Mar 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery for thoracotomies, BMI: 18-25 Kg/m2, American Society of Anesthesiologists(ASA) classification I or II.
Who cannot join
- liver or kidney disease, alcohol dependence, take sedative recently, contraindications for epidural anesthesia.
About this study
Official title: Effects of Thoracic Epidural Anesthesia With Different Local Anesthetics on Propofol Induction
The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction.
- Being tested
- Lidocaine, Bupivacaine, Ropivacaine, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
General anesthesia combined with thoracic epidural 1% lidocaine
BupivacaineDrug
General anesthesia combined with thoracic epidural 0.25% bupivacaine
RopivacaineDrug
General anesthesia combined with thoracic epidural 0.3% ropivacaine
Normal SalineDrug
General anesthesia combined with thoracic epidural 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | General anesthesia combined with thoracic epidural 0.9% normal saline 8ml Receives: Drug: Normal Saline |
| Lidocaine | Experimental | General anesthesia combined with thoracic epidural 1% lidocaine 8ml Receives: Drug: Lidocaine |
| Bupivacaine | Experimental | General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml Receives: Drug: Bupivacaine |
| Ropivacaine | Experimental | General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol Effect-site Concentration
The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
Measured: Before starting anesthesia to finishing endotracheal intubation
Secondary outcomes (3)
Mean Arterial Pressure
The mean arterial pressure of each patient was recorded at five different time points
Measured: Before starting anesthesia to finishing endotracheal intubation
Heart Rate
The heart rate of each patient was recorded at five different time points
Measured: Before starting anesthesia to finishing endotracheal intubation
Bispectral Index Score
The bispectral index(BIS) score of each patient was recorded at two different time points. 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: Before starting anesthesia to finishing endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionMar 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 General AnesthesiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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, Study chair, Dept. of Anesthesiology, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000973
- Sponsor's protocol ID
- 20131012
- Status last verified
- Apr 2014
- First submitted
- 22 Nov 2013
- Last updated
- 16 May 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 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Epidural Anesthesia With Different Local Anesthetics on Propofol Induction
- ClinicalTrials.gov ID
- NCT02000973
- Acronym / sponsor ID
- 20131012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 16 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Normal SalineGeneral anesthesia combined with thoracic epidural 0.9% normal saline 8ml |
| Lidocaine | Experimental | Drug: LidocaineGeneral anesthesia combined with thoracic epidural 1% lidocaine 8ml |
| Bupivacaine | Experimental | Drug: BupivacaineGeneral anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml |
| Ropivacaine | Experimental | Drug: RopivacaineGeneral anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgery for thoracotomies, BMI: 18-25 Kg/m2, American Society of Anesthesiologists(ASA) classification I or II.
Key exclusion criteria (1 listed)
- liver or kidney disease, alcohol dependence, take sedative recently, contraindications for epidural 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 |
|---|---|---|
| LidocaineGeneral anesthesia combined with thoracic epidural 1% lidocaine | Drug | Lidocaine |
| BupivacaineGeneral anesthesia combined with thoracic epidural 0.25% bupivacaine | Drug | Bupivacaine |
| RopivacaineGeneral anesthesia combined with thoracic epidural 0.3% ropivacaine | Drug | Ropivacaine |
| Normal SalineGeneral anesthesia combined with thoracic epidural 0.9% normal saline | Drug | Normal saline |
Primary outcome
Propofol Effect-site Concentration
Time frame: Before starting anesthesia to finishing endotracheal intubation
The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
3 secondary outcomes
Mean Arterial Pressure
Time frame: Before starting anesthesia to finishing endotracheal intubation
Heart Rate
Time frame: Before starting anesthesia to finishing endotracheal intubation
Bispectral Index Score
Time frame: Before starting anesthesia to finishing endotracheal intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for General Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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 study chair
Dept. of Anesthesiology, First Hospital of China Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine, Bupivacaine and Ropivacaine in people with General Anesthesia and Propofol Target-controlled Infusion, run by First Hospital of China Medical University.
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 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 16 May 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?
Propofol Effect-site Concentration (time frame: Before starting anesthesia to finishing endotracheal intubation). 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 16 May 2014.