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

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02143362

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Reaction	Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium Procedure: Awaken test	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine group Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction. Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance. The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.	Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively. Intermittent injection cisatracurium (0.15mg/kg). A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60. Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50. 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. Intermittent injection cisatracurium (0.05mg/kg). Procedure: Awaken test Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test. 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 . Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly . Patients will receive initial anesthesia after finish awaken test.
Placebo Comparator: Control group Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction. Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance. The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.	Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively. Intermittent injection cisatracurium (0.15mg/kg). A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60. Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50. 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. Intermittent injection cisatracurium (0.05mg/kg). Procedure: Awaken test Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test. 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 . Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly . Patients will receive initial anesthesia after finish awaken test.

Arm

Intervention/Treatment

Experimental: Dexmedetomidine group

Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction. Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance. The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.

Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium

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

Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium

Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50. 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. Intermittent injection cisatracurium (0.05mg/kg).

Procedure: Awaken test

Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test. 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 . Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly . Patients will receive initial anesthesia after finish awaken test.

Placebo Comparator: Control group

Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction. Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance. The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.

Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium

Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium

Procedure: Awaken test

Outcome Measures

Primary Outcome Measures

Success rate of awaken test [The whole time of surgery,about 8 hours]
The time from starting to awaken test to patient wakes up [From starting to awaken test to patient wakes up,about 3 hours]
Blood sugar concentration [30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test]
Cortisol concentration [30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test]
Epinephrine concentration [30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test]
Norepinephrine concentration [30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test]

Secondary Outcome Measures

The duration of anesthesia from baseline to patient wake up [From baseline to patient wake up ,about 3 hours]
The dosage of Cisatracurium before patient wakes up [From starting to awaken test to patient wakes up,about 3 hours]
The dosage of propofol before patient wakes up [From starting to awaken test to patient wakes up,about 3 hours]
The dosage of remifentanil before patient wakes up [From starting to awaken test to patient wakes up,about 3 hours]
Heart rate [30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test]
Mean arterial pressure [30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test]
Bispectral electroencephalogram index [30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent.
Ongoing brain functional area surgery with intraoperative wake up.
American Society of Anesthesiologists class I to II.
Aged between 18 and 65 years old.
Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight

Exclusion Criteria:

History of hypertension.
Serious heart,brain,liver,kidney, pulmonary, and endocrine disease or serious infection.
Mental disability or mental disease.
Use of sedative drug.
Suspected or confirmed long term use of narcotic analgesics.
Inability to exchange.
Suspected or confirmed difficult airway.
Suspected of malignant hyperthermia.
Neuromuscular disease.
Allergic to investigational products or with other contraindication.
Subjects who are breastfeeding or pregnant.
Participated in other study within 30 days .