Dual-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy (DLTCI)

NCT ID: NCT02116985

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-10-31

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.

Conditions

Cholecystolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dual-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.

Group Type: EXPERIMENTAL

Dual-loop TCI

Intervention Type: DEVICE

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.

manual

the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.

Group Type: PLACEBO_COMPARATOR

manual

Intervention Type: DEVICE

the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.

Interventions

Dual-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.

Intervention Type: DEVICE

manual

the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role: lead

Responsible Party

bo xu

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 21233500 (View on PubMed)

Other Identifiers

dual-loop

Identifier Type: -

Identifier Source: org_study_id