Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake up
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedJuly 4, 2014
July 1, 2014
1.5 years
May 15, 2014
July 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Dexmedetomidine group
EXPERIMENTAL1. Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction. 2. Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance. 3. The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.
Control group
PLACEBO COMPARATOR1. Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction. 2. Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance. 3. The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.
Interventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2014
First Posted
May 21, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Last Updated
July 4, 2014
Record last verified: 2014-07