Closed-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02114437

Acronym

CLTCI

Enrollment

Registered

2014-04-15

Start date

2014-03-31

Completion date

2015-03-31

Last updated

2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystolithiasis

Keywords

Closed-Loop TCI, NI, Laparoscopic Cholecystectomy

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.

Interventions

DEVICEClosed-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.

DEVICEOpened-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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Narcotrend index	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

Measure	Time frame	Description
induction duration	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

Measure	Time frame	Description
26<NI<46	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.

Countries

China

Contacts

Primary Contactbo xu

xubo333@hotmail.com88653387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026