Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890186
Recruitment Status : Unknown
Verified August 2016 by bo xu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
bo xu, 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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Control infusion of propofol and remifentanil guided by experience




Primary Outcome Measures :
  1. the total dose of propofol and remifentanil [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890186


Contacts
Layout table for location contacts
Contact: bo Xu 88653387 ext 020 xubo333@hotmail.com

Locations
Layout table for location information
China, Guangdong
Guangzhou Military Region General Hospital, Department of Anesthesiology Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Ying Liu    13925189326 ext 86    354109813@qq.com   
Principal Investigator: Ying Liu         
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
Layout table for additonal information
Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02890186    
Other Study ID Numbers: double closed-loop
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Keywords provided by bo xu, Guangzhou General Hospital of Guangzhou Military Command:
narcotrend
propofol
remifentanil
closed-loop of target controlled infusion
Additional relevant MeSH terms:
Layout table for MeSH terms
Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents