CholecystolithiasisPhase 4DLTCINCT02116985
Dual-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy (DLTCI)
A Phase 4 study testing Dual-loop TCI and manual in people with Cholecystolithiasis, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it difficult to judge the depth of anesthesia according to traditional hemodynamics index such as heart rate and blood pressure.In case of this, the… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- Dual-loop TCI and manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Oct 2014
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- require general anesthesia
- expected to last>30 minutes
- 18~90 years
- ASA Ⅰ~Ⅳ level
Who cannot join
- psychiatric illness
- supraspinal neurological disorders
- cranial neurosurgical procedures
- patients equipped with a pacemaker
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
About this study
Official title: Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it difficult to judge the depth of anesthesia according to traditional hemodynamics index such as heart rate and blood pressure.In case of this, the investigators design this research to study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided by a Narcotrend index monitor in Laparoscopic Cholecystectomy.
Read the detailed description
Anesthetics alter electrocortical activity in a dose-dependent manner,and it is suggested that electroencephalographic(EEG)activity can provide a reliable basis for a surrogate measurement of hypnosis.An EEG monitor,the Narcotrend Index(NI),has proven useful to titrate hypnotic drugs.Because it is a single composite measure monitored continuously,it has been used in controlled studies to automatically guide propofol administration.Conversely,automated delivery systems for opioids have seldom been described using EEG activity There are no specific measures to quantify analgesia directly.Nevertheless,in the interaction between opioid-hypnotic synergy and loss of consciousness,when the dose of analgesic administered is sufficient to inhibit autonomic response to noxious stimuli,then the required hypnotic concentration is only that needed to achieve loss of consciousness.Moreover,a noxious stimulus such as laryngoscopy or periosteal pressure to the tibia may cause electrocortical activation with an increase in Narcotrend index,which indirectly reflects the analgesic state or the level of antinociception.Finally,an excitatory EEG arousal reaction resulting from nociceptive stimulation can provide a rational basis for analgesia administration.It can then be hypothesized that Narcotrend index could also be the controlled variable for opioid administration.
- Conditions
- Cholecystolithiasis
- Being tested
- Dual-loop TCI, manual
- Keywords
- Dual-Loop TCI, NI, Laparoscopic Cholecystectomy
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-loop TCIDevice
the controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration.
manualDevice
the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Loop TCI | Experimental | the controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration. Receives: Device: Dual-loop TCI |
| manual | Placebo comparator | the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist. Receives: Device: manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of propofol and remifentanil
record the total dose of propofol and remifentanil from the beginning to the end of anesthesia.
Measured: within two hours from the beginning to the end of the propofol and remifentanil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystolithiasisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116985
- Sponsor's protocol ID
- dual-loop
- Acronym
- DLTCI
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2014
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
PubMed 21233500
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02116985
- Acronym / sponsor ID
- DLTCI / dual-loop
- Conditions
- Cholecystolithiasis
- Keywords
- Dual-Loop TCI, NI, Laparoscopic Cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Apr 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.
Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it difficult to judge the depth of anesthesia according to traditional hemodynamics index such as heart rate and blood pressure.In case of this, the investigators design this research to study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided by a Narcotrend index monitor in Laparoscopic Cholecystectomy.
Detailed description
Anesthetics alter electrocortical activity in a dose-dependent manner,and it is suggested that electroencephalographic(EEG)activity can provide a reliable basis for a surrogate measurement of hypnosis.An EEG monitor,the Narcotrend Index(NI),has proven useful to titrate hypnotic drugs.Because it is a single composite measure monitored continuously,it has been used in controlled studies to automatically guide propofol administration.Conversely,automated delivery systems for opioids have seldom been described using EEG activity There are no specific measures to quantify analgesia directly.Nevertheless,in the interaction between opioid-hypnotic synergy and loss of consciousness,when the dose of analgesic administered is sufficient to inhibit autonomic response to noxious stimuli,then the required hypnotic concentration is only that needed to achieve loss of consciousness.Moreover,a noxious stimulus such as laryngoscopy or periosteal pressure to the tibia may cause electrocortical activation with an increase in Narcotrend index,which indirectly reflects the analgesic state or the level of antinociception.Finally,an excitatory EEG arousal reaction resulting from nociceptive stimulation can provide a rational basis for analgesia administration.It can then be hypothesized that Narcotrend index could also be the controlled variable for opioid administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Loop TCI | Experimental | Device: Dual-loop TCIthe controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration. |
| manual | Placebo comparator | Device: manualthe investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- require general anesthesia
- expected to last>30 minutes
- 18~90 years
- ASA Ⅰ~Ⅳ level
Key exclusion criteria (4 listed)
- psychiatric illness
- supraspinal neurological disorders
- cranial neurosurgical procedures
- patients equipped with a pacemaker
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 |
|---|---|---|
| Dual-loop TCIthe controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration. | Device | Dual-Loop TCI |
| manualthe investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist. | Device | manual |
Primary outcome
The total dose of propofol and remifentanil
Time frame: within two hours from the beginning to the end of the propofol and remifentanil
record the total dose of propofol and remifentanil from the beginning to the end of anesthesia.
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 16 Apr 2015.
- Background: PubMed 21233500Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
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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?
A Phase 4 study testing Dual-loop TCI and manual in people with Cholecystolithiasis, run by Guangzhou General Hospital of Guangzhou Military Command 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 4 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 Apr 2015. 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?
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?
The total dose of propofol and remifentanil (time frame: within two hours from the beginning to the end of the propofol and remifentanil). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116985, which also lists 1 linked publication.
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 Apr 2015.