NCT02143362

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

Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake Up-single Center,Random,Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-12-01
• First posted: 2014-05-21
• Last updated: 2014-07-04