Safety Study of Dexmedetomidine in Elderly Under General Anesthesia
NCT ID: NCT05567523
Last Updated: 2022-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2019-06-01
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Group D0.25, Group D0.5, Group D0.75
Dexmedetomidine will be administered at different initial loading doses (0.25/0.5/0.75 μg/kg within 15min) following same maintained dosage ( 0.5μg/kg/h) in Group D0.25/D0.5/D0.75.
Dexmedetomidine
In dexmedetomidine groups, patients will be pumped 0.1ml/kg of dexmedetomidine (contained dexmedetomidine 0.25/0.5/0.75µg/kg in Group D0.25/D0.5/D0.75) for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation.
Group NS, Group MD
In Group NS, patients will be pumped 0.1ml/kg of normal saline for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation. In Group MD, patients will be administrated with midazolam 0.03mg/kg at the beginning of anesthesia induction.
Normal saline
normal saline
Midazolam
midazolam
Interventions
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Dexmedetomidine
In dexmedetomidine groups, patients will be pumped 0.1ml/kg of dexmedetomidine (contained dexmedetomidine 0.25/0.5/0.75µg/kg in Group D0.25/D0.5/D0.75) for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation.
Normal saline
normal saline
Midazolam
midazolam
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* the health conditions generally well according to medical history, physical examination, and laboratory tests;
* no signs of difficult intubation;
* no history of dementia and mental problems;
* normal cognitive function, ability to understand and comply with study procedures.
Exclusion Criteria
* Heart failure, severe arrhythmias, severe bradycardia (heart rate less than 40 beats/min), atrioventricular block of degree 2 or above, sick sinus syndrome, systolic blood pressure (SBP) ≥180 or \<90 mmHg, diastolic blood pressure (DBP) ≥110 or \<60 mmHg;
* Severe liver or kidney dysfunction, severe infection, and other pathological conditions that interfere with study results.
* Dementia, cerebrovascular accidents within 3 months, mental illness, epilepsy, and other adverse events that interfere with study results.
* Patients with the conditions that block communication and preoperative assessment, such as serious hearing or visual impairment;
* History of chronic analgesic use, long-term psychotropic medication use, alcohol or drug addiction.
65 Years
90 Years
ALL
No
Sponsors
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Zhenjiang First People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Haitong Liu
Role: STUDY_DIRECTOR
Zhenjiang First People's Hospital
Locations
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Zhenjiang First People's Hospital
Zhenjiang, Jiangsu, China
Countries
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References
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Colin PJ, Hannivoort LN, Eleveld DJ, Reyntjens KMEM, Absalom AR, Vereecke HEM, Struys MMRF. Dexmedetomidine pharmacokinetic-pharmacodynamic modelling in healthy volunteers: 1. Influence of arousal on bispectral index and sedation. Br J Anaesth. 2017 Aug 1;119(2):200-210. doi: 10.1093/bja/aex085.
Colin PJ, Hannivoort LN, Eleveld DJ, Reyntjens KMEM, Absalom AR, Vereecke HEM, Struys MMRF. Dexmedetomidine pharmacodynamics in healthy volunteers: 2. Haemodynamic profile. Br J Anaesth. 2017 Aug 1;119(2):211-220. doi: 10.1093/bja/aex086.
Le Bot A, Michelet D, Hilly J, Maesani M, Dilly MP, Brasher C, Mantz J, Dahmani S. Efficacy of intraoperative dexmedetomidine compared with placebo for surgery in adults: a meta-analysis of published studies. Minerva Anestesiol. 2015 Oct;81(10):1105-17. Epub 2015 May 25.
Li Y, Wang B, Zhang LL, He SF, Hu XW, Wong GT, Zhang Y. Dexmedetomidine Combined with General Anesthesia Provides Similar Intraoperative Stress Response Reduction When Compared with a Combined General and Epidural Anesthetic Technique. Anesth Analg. 2016 Apr;122(4):1202-10. doi: 10.1213/ANE.0000000000001165.
Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
Liu Y, Ma L, Gao M, Guo W, Ma Y. Dexmedetomidine reduces postoperative delirium after joint replacement in elderly patients with mild cognitive impairment. Aging Clin Exp Res. 2016 Aug;28(4):729-36. doi: 10.1007/s40520-015-0492-3. Epub 2015 Nov 11.
Mei B, Meng G, Xu G, Cheng X, Chen S, Zhang Y, Zhang M, Liu X, Gu E. Intraoperative Sedation With Dexmedetomidine is Superior to Propofol for Elderly Patients Undergoing Hip Arthroplasty: A Prospective Randomized Controlled Study. Clin J Pain. 2018 Sep;34(9):811-817. doi: 10.1097/AJP.0000000000000605.
Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
Wang BJ, Li CJ, Hu J, Li HJ, Guo C, Wang ZH, Zhang QC, Mu DL, Wang DX. Impact of dexmedetomidine infusion during general anaesthesia on incidence of postoperative delirium in elderly patients after major non-cardiac surgery: study protocol of a randomised, double-blinded and placebo-controlled trial. BMJ Open. 2018 Apr 21;8(4):e019549. doi: 10.1136/bmjopen-2017-019549.
Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.
Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22.
Liu H, Gao M, Zheng Y, Sun C, Lu Q, Shao D. Effects of dexmedetomidine at different dosages on perioperative haemodynamics and postoperative recovery quality in elderly patients undergoing hip replacement surgery under general anaesthesia: a randomized controlled trial. Trials. 2023 Jun 8;24(1):386. doi: 10.1186/s13063-023-07384-z.
Other Identifiers
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SQK-20190131-W
Identifier Type: -
Identifier Source: org_study_id
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