The Effect on the Older's Cognition of Dual-loop Target Controlled Infusion Guided by Narcotrend Index

NCT03010098 | Unknown Phase 4

• 1 other identifier: double closed-loop and POCD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect on older's cognition of the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index .

Conditions

Anesthesia

Keywords

POCD; narcotrend; closed-loop of target controlled infusion

Outcome Measures

Primary Outcomes (1)

• MMSE scores

  The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.We measure the patient before the operation and the first/third/seventh day after the operation.

  up to 1 week

Secondary Outcomes (1)

• protein s100beta

  up to 24 hours

Other Outcomes (1)

• NSE

  up to 24 hours

Study Arms (2)

Dual-Loop TCI

EXPERIMENTAL

the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.

Device: Dual-Loop TCI

Open-Loop TCI

EXPERIMENTAL

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.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.

Device: Open-Loop TCI

Interventions

Dual-Loop TCI DEVICE

the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46

Also known as: Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Inde

Dual-Loop TCI

Open-Loop TCI 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.

Also known as: Control infusion of propofol and remifentanil guided by experience

Open-Loop TCI

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
• Written informed consent from the patient or the relatives of the participating patient.
• BMI:18.0～25 kg/m2

You may not qualify if:

• Mental illness can not match
• epidural anesthesia contraindicated
• People who have Slow-type arrhythmias
• Chronic renal failure
• Alcohol or drug abuse
• Already taking gabapentin, pregabalin, benzodiazepin or antidepression dru

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 4, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2017-01

Locations

CN (1)