The Study of Different Sedative Medications in Monitored Anesthesia Care During Eye Surgery With Local Anesthesia
NCT ID: NCT04018703
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-11-01
2021-12-31
Brief Summary
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1. The patient with local anesthesia without sedation is in a state of awareness, which will cause intense stress resulting in increased blood pressure, heart rate, muscle tension and even sense of pain;
2. Traction of extraocular muscles and eyeballs can induce oculocardiac reflex, followed by bradycardia, atrial or ventricular arrhythmia, conduction block, and even more worsen, life-threatening cardiac arrest may occur;
3. With the increase in average life expectancy and the improvement of quality of life requirements, the number of elderly patients in ophthalmic surgery is also increasing. These elderly patients are often combined with hypertension, diabetes, etc. and decreased tolerance of with general anesthesia;
4. For some retinal detachment surgery with difficulty in resetting, the patients will be required to change to the prone position immediately after surgery to improve the success rate of resetting. Conventional general anesthesia management are cumbersome and costly, which may not be likely to achieve the swift emergence.
Nowadays, monitoring Anesthesia Care (MAC) has developed into a flexible and unique anesthesia technology combining intravenous anesthesia with regional block anesthesia. MAC provides reasonable balance between economy, comfort and safety, efficiency by continuous monitoring of changes in respiratory and circulatory system, during process of sedation and analgesia. Airway management will be another issue as surgeons operate on the side of head and face. Studies have shown that MAC can achieve adequate sedation and analgesia to decrease blood pressure, provide acceptable surgical fields and reduce adverse reactions such as perioperative stress, pain and anxiety. Meanwhile, MAC make patients comfortable enough to cooperate with the surgeons, easy to be awakened with relatively short operation duration and improvement of perioperative safety.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dexmedetomidine
Dexmedetomidine will be used for perioperative sedation.
Dexmedetomidine
loading dose 0.5-2.5ug/kg followed by continuous infusion 0.2-0.5ug/kg/h
Midazolam
Midazolam will be used for perioperative sedation.
Midazolam
loading dose 30-50ug/kg followed by continuous infusion 10-30ug/kg/h
Interventions
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Dexmedetomidine
loading dose 0.5-2.5ug/kg followed by continuous infusion 0.2-0.5ug/kg/h
Midazolam
loading dose 30-50ug/kg followed by continuous infusion 10-30ug/kg/h
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Hui Qiao
Attending Anesthesiologist
Principal Investigators
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Wenxian Li, M.D. Ph.D.
Role: STUDY_DIRECTOR
Eye and ENT Hospital of Fudan University
Locations
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Eye, Ear, Nose and Throat Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAC in Eye Surgery
Identifier Type: -
Identifier Source: org_study_id