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

NCT02890186 | Unknown Phase 4

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

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.

Conditions

Anesthesia

Keywords

narcotrend; propofol; remifentanil; closed-loop of target controlled infusion

Outcome Measures

Primary Outcomes (1)

• 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

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.

Device: Narcotrend

manual

PLACEBO COMPARATOR

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

Interventions

Narcotrend 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 Index

Dual-Loop TCI

experience OTHER

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

manual

Eligibility Criteria

• Age: 23 Years - 65 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 drug

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

RECRUITING

MeSH Terms

Interventions

Ecological Momentary Assessment

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

bo Xu

CONTACT

88653387; xubo333@hotmail.com

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: August 16, 2016
• First Posted: September 7, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-08

Locations

CN (1)