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

Primary Purpose

Cholecystolithiasis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Closed-loop TCI
Opened-loop TCI
Sponsored by
Guangzhou General Hospital of Guangzhou Military Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cholecystolithiasis focused on measuring Closed-Loop TCI, NI, Laparoscopic Cholecystectomy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guangzhou Military Region General Hospital, Department of AnesthesiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Closed-loop TCI

Opened-loop TCI

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2014
Last Updated
March 11, 2015
Sponsor
Guangzhou General Hospital of Guangzhou Military Command
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1. Study Identification

Unique Protocol Identification Number
NCT02114437
Brief Title
Closed-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy
Acronym
CLTCI
Official Title
Closed-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou General Hospital of Guangzhou Military Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
Keywords
Closed-Loop TCI, NI, Laparoscopic Cholecystectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closed-loop TCI
Arm Type
Experimental
Arm Description
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.
Arm Title
Opened-loop TCI
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Closed-loop TCI
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Opened-loop TCI
Intervention Description
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 Measure Information:
Title
Narcotrend index
Description
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.
Time Frame
5minutes
Secondary Outcome Measure Information:
Title
induction duration
Description
duration of induction defined as the time elapsed from the start of propofol administration to the moment when the NI value decreased to <46
Time Frame
within 10 minutes from the start of of propofol administration
Other Pre-specified Outcome Measures:
Title
26<NI<46
Description
percentage of time in which the NI index between 26 and 46 during the maintenance.
Time Frame
within two hours from the beginning to the end of the infusion of propofol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bo xu
Phone
88653387
Ext
020
Email
xubo333@hotmail.com
Facility Information:
Facility Name
Guangzhou Military Region General Hospital, Department of Anesthesiology
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liuxun Li
Phone
13631387935
Ext
86
Email
276978230@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21233500
Citation
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.
Results Reference
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Closed-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy

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