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Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.
After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm P | Active Comparator | Placebo infusion |
|
| Arm D | Experimental | Dexmedetomidine infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo (saline) iv. during the operation and stoped 30min before end of the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium | Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours | every 8 hours within 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of PACU stay | Length of PACU stay (min) | during PACU stay |
| hemodynamic parameters | Heart frequency, systolic blood pressure, diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Mei, M.D. | Contact | 00862783663173 | wmei@tjh.tjmu.edu.cn | |
| Yuke Tian, M.D. | Contact | 00862783663173 | yktian@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yuke Tian, M.D. | Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Study Chair |
| Chuanhan Zhang, MD. | Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexmedetomidine | Drug | Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery |
|
| every 5min during operation and every 15min during PACU stay |
| incidence of postoperative nausea and vomiting | incidence of postoperative nausea and vomiting | 24 postoperative hours |
| quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS) | quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS) | 24 postoperative hours |
| Postoperative delirium | Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours | 1st, 2nd, 3rd postoperative days |
| Postoperative Stroke | Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score). | 1st, 2nd, 3rd, 7th postoperative days |
| Study Director |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |