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

Sponsor

Guangzhou General Hospital of Guangzhou Military Command (Other)

Overall Status

Unknown status

CT.gov ID

NCT02890186

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: Narcotrend Other: experience	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Narcotrend 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. Other Names: Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index
Placebo Comparator: 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.	Other: experience 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 Names: Control infusion of propofol and remifentanil guided by experience

Arm

Intervention/Treatment

Experimental: 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.

Device: Narcotrend

Other Names:

Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Index

Placebo Comparator: 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.

Other: experience

Other Names:

Control infusion of propofol and remifentanil guided by experience

Outcome Measures

Primary Outcome Measures

the total dose of propofol and remifentanil [within three hours from the beginning to the end of the propofol and remifentanil]
record the total dose of propofol and remifentanil from the beginning to the end of anesthesia

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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