Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake up

NCT02143362 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-07-04

No results posted yet for this study

Summary

The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.

Conditions

  • Anesthesia; Reaction

Interventions

DRUG

Anesthesia induction,propofol, remifentanil ,cisatracurium

1. Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively. 2. Intermittent injection cisatracurium (0.15mg/kg). 3. A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.

DRUG

Anesthesia maintenance , propofol,remifentanil,cisatracurium

1. Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50. 2. Target Controlled Infusion remifentanil , targeted plasma concentrations are 3\~6ng/ml ,maintain heart rate to 60\~100 beats per minute and mean blood pressure to 70\~105 mmHg. 3. Intermittent injection cisatracurium (0.05mg/kg).

PROCEDURE

Awaken test

1. Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test. 2. In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group . 3. Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration. 4. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly . 5. Patients will receive initial anesthesia after finish awaken test.

Sponsors & Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143362 on ClinicalTrials.gov