Anesthesia; Reaction
Conditions
Keywords
Intraoperative wake up, Closed loop of target controlled infusion, Dexmedetomidine, Propofol
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.
Interventions
DRUGAnesthesia 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.
DRUGAnesthesia 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).
PROCEDUREAwaken 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
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The duration of anesthesia from baseline to patient wake up | From baseline to patient wake up ,about 3 hours |
| 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 |
| 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 |
Outcome results
None listed