Anesthesia; ReactionPhase 4NCT02143362
Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake up
A Phase 4 study testing Anesthesia induction,propofol, remifentanil ,cisatracurium, Anesthesia maintenance , propofol,remifentanil,cisatracurium and Awaken test in people with Anesthesia; Reaction, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial summary
The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia; Reaction
- What is being tested?
- Anesthesia induction,propofol, remifentanil ,cisatracurium, Anesthesia maintenance , propofol,remifentanil,cisatracurium and Awaken test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2015
- 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
- Written informed consent.
- Ongoing brain functional area surgery with intraoperative wake up.
- American Society of Anesthesiologists class I to II.
- Aged between 18 and 65 years old.
- Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight
Who cannot join
- History of hypertension.
- Serious heart,brain,liver,kidney, pulmonary, and endocrine disease or serious infection.
- Mental disability or mental disease.
- Use of sedative drug.
- Suspected or confirmed long term use of narcotic analgesics.
- Inability to exchange.
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- Suspected or confirmed difficult airway.
- Suspected of malignant hyperthermia.
- Neuromuscular disease.
- Allergic to investigational products or with other contraindication.
- Subjects who are breastfeeding or pregnant.
- Participated in other study within 30 days .
About this study
Official title: Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake Up-single Center,Random,Controlled Trial
The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.
- Conditions
- Anesthesia; Reaction
- Being tested
- Anesthesia induction,propofol, remifentanil ,cisatracurium, Anesthesia maintenance , propofol,remifentanil,cisatracurium, Awaken test
- Keywords
- Intraoperative wake up, Closed loop of target controlled infusion, Dexmedetomidine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia induction,propofol, remifentanil ,cisatracuriumDrug
- Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.
- Intermittent injection cisatracurium (0.15mg/kg).
- A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.
Anesthesia maintenance , propofol,remifentanil,cisatracuriumDrug
- Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.
- Target Controlled Infusion remifentanil , targeted plasma concentrations are 3~6ng/ml ,maintain heart rate to 60~100 beats per minute and mean blood pressure to 70~105 mmHg.
- Intermittent injection cisatracurium (0.05mg/kg).
Awaken testProcedure or surgery
- Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.
- In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group .
- Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.
- Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .
- Patients will receive initial anesthesia after finish awaken test.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | 1. Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction.
2. Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance.
3. The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test. Receives: Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium; Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium; Procedure: Awaken test |
| Control group | Placebo comparator | 1. Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction.
2. Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance.
3. The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test. Receives: Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium; Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium; Procedure: Awaken test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of awaken test
Measured: The whole time of surgery,about 8 hours
The time from starting to awaken test to patient wakes up
Measured: From starting to awaken test to patient wakes up,about 3 hours
Blood sugar concentration
Measured: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Cortisol concentration
Measured: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Epinephrine concentration
Measured: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Norepinephrine concentration
Measured: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Secondary outcomes (7)
The duration of anesthesia from baseline to patient wake up
Measured: From baseline to patient wake up ,about 3 hours
The dosage of Cisatracurium before patient wakes up
Measured: From starting to awaken test to patient wakes up,about 3 hours
The dosage of propofol before patient wakes up
Measured: From starting to awaken test to patient wakes up,about 3 hours
The dosage of remifentanil before patient wakes up
Measured: From starting to awaken test to patient wakes up,about 3 hours
Heart rate
Measured: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Mean arterial pressure
Measured: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Bispectral electroencephalogram index
Measured: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; ReactionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143362
- Sponsor's protocol ID
- Dex anesthesia
- Status last verified
- Jul 2014
- First submitted
- 15 May 2014
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake Up-single Center,Random,Controlled Trial
- ClinicalTrials.gov ID
- NCT02143362
- Acronym / sponsor ID
- Dex anesthesia
- Conditions
- Anesthesia; Reaction
- Keywords
- Intraoperative wake up, Closed loop of target controlled infusion, Dexmedetomidine, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 21 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.
The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium, Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium, Procedure: Awaken test1. Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction. 2. Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance. 3. The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test. |
| Control group | Placebo comparator | Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium, Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium, Procedure: Awaken test1. Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction. 2. Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance. 3. The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent.
- Ongoing brain functional area surgery with intraoperative wake up.
- American Society of Anesthesiologists class I to II.
- Aged between 18 and 65 years old.
- Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight
Key exclusion criteria (12 listed)
- History of hypertension.
- Serious heart,brain,liver,kidney, pulmonary, and endocrine disease or serious infection.
- Mental disability or mental disease.
- Use of sedative drug.
- Suspected or confirmed long term use of narcotic analgesics.
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 |
|---|---|---|
| Anesthesia induction,propofol, remifentanil ,cisatracurium1. Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively. 2. Intermittent injection cisatracurium (0.15mg/kg). 3. A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60. | Drug | Control group, Dexmedetomidine group |
| Anesthesia maintenance , propofol,remifentanil,cisatracurium1. Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50. 2. Target Controlled Infusion remifentanil , targeted plasma concentrations are 3~6ng/ml ,maintain heart rate to 60~100 beats per minute and mean blood pressure to 70~105 mmHg. 3. Intermittent injection cisatracurium (0.05mg/kg). | Drug | Control group, Dexmedetomidine group |
| Awaken test1. Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test. 2. In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group . 3. Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration. 4. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly . 5. Patients will receive initial anesthesia after finish awaken test. | Procedure or surgery | Control group, Dexmedetomidine group |
Primary outcome
Success rate of awaken test
Time frame: The whole time of surgery,about 8 hours
The time from starting to awaken test to patient wakes up
Time frame: From starting to awaken test to patient wakes up,about 3 hours
Blood sugar concentration
Time frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Cortisol concentration
Time frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Epinephrine concentration
Time frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Norepinephrine concentration
Time frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
7 secondary outcomes
The duration of anesthesia from baseline to patient wake up
Time frame: From baseline to patient wake up ,about 3 hours
The dosage of Cisatracurium before patient wakes up
Time frame: From starting to awaken test to patient wakes up,about 3 hours
The dosage of propofol before patient wakes up
Time frame: From starting to awaken test to patient wakes up,about 3 hours
The dosage of remifentanil before patient wakes up
Time frame: From starting to awaken test to patient wakes up,about 3 hours
Heart rate
Time frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Mean arterial pressure
Time frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Bispectral electroencephalogram index
Time frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anesthesia induction,propofol, remifentanil ,cisatracurium, Anesthesia maintenance , propofol,remifentanil,cisatracurium and Awaken test in people with Anesthesia; Reaction, run by Second Affiliated Hospital of Xi'an Jiaotong 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 5 inclusion and 12 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 4 Jul 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?
Results are not available in the source record.
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?
Success rate of awaken test (time frame: The whole time of surgery,about 8 hours). The study lists 6 primary outcomes in all. 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 4 Jul 2014.