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Closed-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy (CLTCI)

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ClinicalTrials.gov Identifier: NCT02114437
Recruitment Status : Unknown
Verified March 2015 by bo xu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : April 15, 2014
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
bo xu, Guangzhou General Hospital of Guangzhou Military Command

Brief 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 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.

Condition or disease Intervention/treatment Phase
Cholecystolithiasis Device: Closed-loop TCI Device: Opened-loop TCI Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Closed-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index in Laparoscopic Cholecystectomy
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Closed-loop TCI
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.
Device: Closed-loop TCI
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.

Placebo Comparator: Opened-loop TCI
the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits to maintain NI at approximately 36 within a range of 26 to 46 to the extent possible.
Device: Opened-loop TCI
the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits to maintain NI at approximately 36 within a range of 26 to 46 to the extent possible.




Primary Outcome Measures :
  1. Narcotrend index [ Time Frame: 5minutes ]
    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.The error size determines which drug will be modified:if the NI error is small,only the remifentanil is changed;if the NI error is higher,the two drug concentrations are changed.


Secondary Outcome Measures :
  1. induction duration [ Time Frame: within 10 minutes from the start of of propofol administration ]
    duration of induction defined as the time elapsed from the start of propofol administration to the moment when the NI value decreased to <46


Other Outcome Measures:
  1. 26<NI<46 [ Time Frame: within two hours from the beginning to the end of the infusion of propofol ]
    percentage of time in which the NI index between 26 and 46 during the maintenance.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. require general anesthesia
  2. expected to last>30 minutes
  3. 18~90 years
  4. ASA Ⅰ~Ⅳ level

Exclusion Criteria:

  1. psychiatric illness
  2. supraspinal neurological disorders
  3. cranial neurosurgical procedures
  4. patients equipped with a pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114437


Contacts
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Contact: bo xu 88653387 ext 020 xubo333@hotmail.com

Locations
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China, Guangdong
Guangzhou Military Region General Hospital, Department of Anesthesiology Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Liuxun Li    13631387935 ext 86    276978230@qq.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command

Publications:
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Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02114437     History of Changes
Other Study ID Numbers: Closed-Loop
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015

Keywords provided by bo xu, Guangzhou General Hospital of Guangzhou Military Command:
Closed-Loop TCI
NI
Laparoscopic Cholecystectomy

Additional relevant MeSH terms:
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Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents