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

Anesthesia Clinical Trial

— POCD;TCI  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03010098
• Other study ID #: double closed-loop and POCD
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 20, 2016
• Last updated: January 2, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

Description:

Two hundreds of patients scheduled for surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=100) and open-loop group(group B,n=100).The procedure during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was controlled manually.Taking an exam of MMSE before and after the surgery which measures if the older's cognition changed. Furthermore.we will measure the levels of protein S100beta and NSE.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. ASA ? ~ ? women undergoing Laparoscopic surgery.

2. Written informed consent from the patient or the relatives of the participating patient.

3. BMI:18.0~25 kg/m2

Exclusion Criteria:

1. Mental illness can not match

2. epidural anesthesia contraindicated

3. People who have Slow-type arrhythmias

4. Chronic renal failure

5. Alcohol or drug abuse

6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression dru

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Dual-Loop TCI
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
• Open-Loop TCI
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.

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NSE	NSE has a role in glucose metabolism. As for S100b, NSE is released from the hypoxic brain into the bloodstream, and its serum level correlates with the extent of brain injury. Also, NSE correlates with other markers of brain injury . NSE has a high specificity to predict adverse outcomes when measured in the few days post CA. A cutoff point of 33 mg/l is recommended.in our study, we take the blood sample before the operation and after the operation when the patient awake.	up to 24 hours	Yes
Primary	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	Yes
Secondary	protein s100beta	The calcium-binding protein S100b is enriched in astroglial cells and can cross the blood-brain barrier after hypoxic damage of the central nervous system. Its routine measurement is simple and relatively inexpensive. S100b is filtrated by the kidney and has an estimated half-life of 2 h . Its serum level increases after CA, and its prognostic value has been studied . Because of mitigated results, its routine use has been, up to now, not recommended. S100bata is normally 0.2µg/L in serum or more smaller.We decide to take the blood sample before the operation and after the operation when the patient is awake.	up to 24 hours	Yes