Clinical trial NCT02143362: Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake up
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia; Reaction
Keywords: Intraoperative wake up
Closed loop of target controlled infusion
Dexmedetomidine
Propofol
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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 .

Primary outcomes:
measure: Success rate of awaken test
timeFrame: The whole time of surgery,about 8 hours
measure: The time from starting to awaken test to patient wakes up
timeFrame: From starting to awaken test to patient wakes up,about 3 hours
measure: Blood sugar concentration
timeFrame: 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
measure: Cortisol concentration
timeFrame: 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
measure: Epinephrine concentration
timeFrame: 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
measure: Norepinephrine concentration
timeFrame: 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 outcomes:
measure: The duration of anesthesia from baseline to patient wake up
timeFrame: From baseline to patient wake up ,about 3 hours
measure: The dosage of Cisatracurium before patient wakes up
timeFrame: From starting to awaken test to patient wakes up,about 3 hours
measure: The dosage of propofol before patient wakes up
timeFrame: From starting to awaken test to patient wakes up,about 3 hours
measure: The dosage of remifentanil before patient wakes up
timeFrame: From starting to awaken test to patient wakes up,about 3 hours
measure: Heart rate
timeFrame: 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
measure: Mean arterial pressure
timeFrame: 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
measure: Bispectral electroencephalogram index
timeFrame: 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
Other outcomes:
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