Closed-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Closed-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index in Laparoscopic Cholecystectomy

Conditions
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Cholecystolithiasis

Intervention / Treatment
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* Device: Closed-loop TCI
* Device: Opened-loop TCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: require general anesthesia expected to last>30 minutes 18 90 years ASA Ⅰ Ⅳ level Exclusion Criteria: psychiatric illness supraspinal neurological disorders cranial neurosurgical procedures patients equipped with a pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed-loop TCI<br>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<br>* 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.<br>|
| Placebo Comparator: Opened-loop TCI<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotrend index | 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. | 5minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction duration | duration of induction defined as the time elapsed from the start of propofol administration to the moment when the NI value decreased to <46 | within 10 minutes from the start of of propofol administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed-Loop TCI, Laparoscopic Cholecystectomy, NI