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

Phase 4

• Conditions: Anesthesia
• Interventions: Device: Narcotrend; Other: experience

• Registration Number: NCT02890186
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

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.

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 Timeline

• Study Start: 2016-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Posted: 2016-09-07
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. ASA Ⅰ ~ Ⅱ 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 drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual-Loop TCI	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.
manual	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology; 🇨🇳 Guangzhou, Guangdong, China