How Different Sedatives Affect Hip Fracture Patient's Postoperative Delirium
NCT03346226 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2017-12-13
Summary
the hypothesis is that Dexmedetomidine seems to decrease incidence of post-operative delirium . one possible mechanism is that Dex have a minor influence on cognition, since it has no effect on GABA receptor,another is that Dex could induce a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients.
In this study , investigators devise the two different sedatives(Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia
Conditions
- Delirium in Old Age
Interventions
- DRUG
-
Dexmedetomidine Hydrochloride
Dexmedetomidine is given to patients during spinal anesthesia at the dose of 0.5 μg/kg,adjusted the dose to keep BIS between 70-80 until 30 minutes before the end of surgery
- DRUG
-
Propofol
Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts,adjust the propofol's dose to keep BIS between 70-80 before the end of surgery
Sponsors & Collaborators
-
First Affiliated Hospital of Guangxi Medical University
collaborator OTHER -
The Second Affiliated Hospital of Harbin Medical University
collaborator OTHER -
The First Affiliated Hospital of Nanchang University
collaborator OTHER -
Qianfoshan Hospital
collaborator OTHER -
Shanghai 6th People's Hospital
collaborator OTHER -
Tang-Du Hospital
collaborator OTHER -
Second Hospital of Shanxi Medical University
collaborator OTHER -
The First Affiliated Hospital of Soochow University
collaborator OTHER -
Shanghai Changzheng Hospital
collaborator OTHER -
The Fuzhou No 2 Hospital
collaborator OTHER -
Foshan Hospital of Traditional Chinese Medicine
collaborator OTHER -
Beijing Jishuitan Hospital
collaborator OTHER -
Shanghai Zhongshan Hospital
lead OTHER
Principal Investigators
-
Xue ZhangGang, doctor · Anesthesiology Department of Shanghai Zhongshan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-01
- Primary Completion
- 2018-12-30
- Completion
- 2019-06-30
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