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| Name | Class |
|---|---|
| Shanghai 8th People's Hospital | OTHER |
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Postoperative delirium(POD)is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuroleptanalgesia group | Experimental | Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure. |
|
| Control group | Placebo Comparator | The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose neuroleptanalgesia | Drug | Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery | Up to 7 days after surgery(or leaving hospital) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 7 days | |
| Incidence of postoperative nausea and vomiting | Up to 7 days after surgery(or leaving hospital) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, Doctor | Contact | 18616514088 | 184872238@qq.com | |
| Zhenling Huang, Doctor | Contact | 18964381971 | 2993252569@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Diansan Su, Doctor | RenJi Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| Placebo | Drug | The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure. |
|
| Patients' satisfaction | This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied) | Up to 7 days after surgery(or leaving hospital) |
| Incidence of postoperative hypoxia | Up to 1 day after surgery |
| Incidence of major serious complications and serious arrhythmia | Up to 7 days after surgery(or leaving hospital) |
| Duration of postoperative delirium | Up to 7 days after surgery(or leaving hospital) |
| Shanghai Eighth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D012811 | Sigmoid Neoplasms |
| D008113 | Liver Neoplasms |
| D007680 | Kidney Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D011471 | Prostatic Neoplasms |
| D050723 | Fractures, Bone |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012810 | Sigmoid Diseases |
| D008107 | Liver Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D014947 | Wounds and Injuries |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009458 | Neuroleptanalgesia |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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