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

Closed-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.

Study Overview

• Status: Unknown
• Conditions: Cholecystolithiasis
• Intervention / Treatment: Device: Closed-loop TCI; Device: Opened-loop TCI

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 Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • Recruiting
      • Guangzhou Military Region General Hospital, Department of Anesthesiology
      • Contact: Liuxun Li; Phone Number: 86 13631387935; Email: 276978230@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
26<NI<46	percentage of time in which the NI index between 26 and 46 during the maintenance.	within two hours from the beginning to the end of the infusion of propofol

Collaborators and Investigators

• Sponsor: Guangzhou General Hospital of Guangzhou Military Command

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: April 13, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): March 12, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Laparoscopic Cholecystectomy; NI; Closed-Loop TCI
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: Closed-Loop