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

NCT02116985 | Completed Phase 4

• 1 other identifier: dual-loop
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystolithiasis

Keywords

Dual-Loop TCI; NI; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• The total dose of propofol and remifentanil

  record the total dose of propofol and remifentanil from the beginning to the end of anesthesia.

  within two hours from the beginning to the end of the propofol and remifentanil

Study Arms (2)

Dual-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: Dual-loop TCI

manual

PLACEBO COMPARATOR

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.

Device: manual

Interventions

Dual-loop TCI 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.

Dual-Loop TCI

manual 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.

manual

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

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: 21233500 BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

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: April 15, 2014
• First Posted: April 17, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

CN (1)