Due to the delicacy and long duration of the procedure, ophthalmic surgery put forward higher requirements to anesthesia management:
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.
Condition or disease | Intervention/treatment | Phase |
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Balanced Anesthesia Adjuvants,Anesthesia | Drug: Dexmedetomidine Drug: Midazolam | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effective Dose of Dexmedetomidine or Midazolam in Monitored Anesthesia Care for Patients Undergoing Ophthalmologic Surgery With Retrobulbar Nerve Block |
Actual Study Start Date : | November 1, 2019 |
Estimated Primary Completion Date : | July 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Experimental: Dexmedetomidine
Dexmedetomidine will be used for perioperative sedation.
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Drug: Dexmedetomidine
loading dose 0.5-2.5ug/kg followed by continuous infusion 0.2-0.5ug/kg/h
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Experimental: Midazolam
Midazolam will be used for perioperative sedation.
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Drug: Midazolam
loading dose 30-50ug/kg followed by continuous infusion 10-30ug/kg/h
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hui Qiao, M.D. Ph.D. | 8615900598163 | theyellow@163.com | |
Contact: Weihong Yang, M.D. | 8618917785802 | yangweihong@eentanesthesia.com |
China, Shanghai | |
Eye, Ear, Nose and Throat Hospital | Recruiting |
Shanghai, Shanghai, China, 200031 | |
Contact: Hui Qiao, Doctor 021-64377134 qiaohui@eentanesthesia.com |
Study Director: | Wenxian Li, M.D. Ph.D. | Eye and ENT Hospital of Fudan University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 9, 2019 | ||||||||
First Posted Date ICMJE | July 12, 2019 | ||||||||
Last Update Posted Date | November 3, 2020 | ||||||||
Actual Study Start Date ICMJE | November 1, 2019 | ||||||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Study of Different Sedative Medications in Monitored Anesthesia Care During Eye Surgery With Local Anesthesia | ||||||||
Official Title ICMJE | Effective Dose of Dexmedetomidine or Midazolam in Monitored Anesthesia Care for Patients Undergoing Ophthalmologic Surgery With Retrobulbar Nerve Block | ||||||||
Brief Summary |
Due to the delicacy and long duration of the procedure, ophthalmic surgery put forward higher requirements to anesthesia management:
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. |
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Detailed Description | The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not possible to be blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
150 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04018703 | ||||||||
Other Study ID Numbers ICMJE | MAC in Eye Surgery | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hui Qiao, Eye & ENT Hospital of Fudan University | ||||||||
Study Sponsor ICMJE | Eye & ENT Hospital of Fudan University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Eye & ENT Hospital of Fudan University | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |