Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index

Study Overview
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Brief Summary
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To investigate the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index in the anterior cervical decompression and fusion with internal fixation surgery.

Detailed Description
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Sixty patients scheduled for anterior cervical decompression and fusion with internal fixation surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=30) and open-loop group(group B,n=30).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.

Official Title
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Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index in Anterior Cervical Decompression and Fusion With Internal Fixation

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Narcotrend
* Other: experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 drug

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual-Loop TCI<br>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. | Device: Narcotrend<br>* 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.<br>* Other names: Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index;|
| Placebo Comparator: manual<br>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. | Other: experience<br>* 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.<br>* Other names: Control infusion of propofol and remifentanil guided by experience;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total dose of propofol and remifentanil | record the total dose of propofol and remifentanil from the beginning to the end of anesthesia | within three hours from the beginning to the end of the propofol and remifentanil | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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narcotrend, propofol, remifentanil, closed-loop of target controlled infusion