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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine will be used for perioperative sedation. |
|
| Midazolam | Experimental | Midazolam will be used for perioperative sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | loading dose 0.5-2.5ug/kg followed by continuous infusion 0.2-0.5ug/kg/h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative change of Observer's Assessment of Alertness/Sedation scale (OAA/S) | Conventional subjective sedation scales with 1 to 5. Successful sedation was defined as an OAA/S scale score between 1 and 3, while failure was defined as an OAA/S score of more than 3. | OAA/S score will be recorded from patient arrival in the operating room to about 30 minutes after surgery at following time points: before sedative administration, before skin incision, every 5 minutes intraoperatively and every 10 minutes in PACU. |
| Numerical rating scale (NRS) | The surgeons rated anesthesia management on a numerical rating scale (NRS), ranging from 0 to 10, with 10 defined as the best condition and 0 as the worst. | Immediately after surgery, the surgeons report NRS only once |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Measured with Tono-Pen tonometer | Intraocular pressure will be measured at two time points: before sedative medication administration and before skin incision. |
| Bispectral index (BIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Qiao, M.D. Ph.D. | Contact | 8615900598163 | theyellow@163.com | |
| Weihong Yang, M.D. | Contact | 8618917785802 | yangweihong@eentanesthesia.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenxian Li, M.D. Ph.D. | Eye and ENT Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye, Ear, Nose and Throat Hospital | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | loading dose 30-50ug/kg followed by continuous infusion 10-30ug/kg/h |
|
Anesthesia depth index
| Bis will be continuously recorded with BIS monitor from arrival in the operating room to discharge to ward (about 30 minutes after surgery). |
| Visual analogue scale (VAS) | Patient self-report pain score ranging from 0 to 10, with 0 defined as no pain at all and 10 as the intolerable pain. | VAS will be recorded at the following time points until 1h postoperatively: before sedative medication administration, before skin incision, every 10 minutes intraoperatively and 1h postoperatively |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |