NCT02114437

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

March 28, 2014

Last Update Submit

March 11, 2015

Conditions

Cholecystolithiasis

Keywords

Closed-Loop TCINILaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • induction duration

    within 10 minutes from the start of of propofol administration

Other Outcomes (1)

  • 26<NI<46

    within two hours from the beginning to the end of the infusion of propofol

Study Arms (2)

Closed-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.

Device: Closed-loop TCI

Opened-loop TCI

PLACEBO COMPARATOR

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

Interventions

Closed-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.

Closed-loop TCI
Opened-loop TCIDEVICE

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.

Opened-loop TCI

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • require general anesthesia
  • expected to last\>30 minutes
  • \~90 years
  • ASA Ⅰ\~Ⅳ level

You may not qualify if:

  • psychiatric illness
  • supraspinal neurological disorders
  • cranial neurosurgical procedures
  • patients equipped with a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21233500BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Central Study Contacts

bo xu

CONTACT

88653387xubo333@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 15, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

CN(1)