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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02890186

Enrollment

Registered

2016-09-07

Start date

2016-04-30

Completion date

2016-09-30

Last updated

2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

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

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.

Interventions

DEVICENarcotrend

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.

OTHERexperience

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary Contactbo Xu

xubo333@hotmail.com88653387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026