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The purpose of this study is to find out appropriate dose range of dexmedetomidine to provide the elderly patients satisfactory sedation and analgesia with stable hemodynamics during perioperative period of hip replacement under general anesthesia.
All patients will be screened to determine eligibility for study entry, and the patients who meet the eligibility requirements will be informed about the study and potential risks. After giving written informed consent, the patients will be randomized into different doses of dexmedetomidine groups and the comparative groups in a same ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D0.25, Group D0.5, Group D0.75 | Experimental | 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. |
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| Group NS, Group MD | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of baseline blood pressure | Changes of baseline blood pressure in each group, including systolic blood pressure, diastolic blood pressure and mean arterial pressure | Through the whole perioperative period, an average of 10 hours |
| Changes of baseline heart rate | Changes of baseline heart rate in each group | Through the whole perioperative period, an average of 10 hours |
| Numbers of elderly patients with hypotension | Hypotension is defined as systolic blood pressure <90 mmHg or mean arterial pressure below >20% of basal values. | Through the whole perioperative period, an average of 10 hours |
| Numbers of elderly patients with bradycardia | Bradycardia is defined as heart rate <50 beats/min or below >20% of basal values. | Through the whole perioperative period, an average of 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation changes after general anesthesia using Richmond agitation-sedation scale | Sedation changes after general anesthesia using Richmond agitation-sedation scale(-5 to +4, 0 means awake and quiet) in each group | before general anesthesia, up to 2 hours after general anesthesia |
| Pain changes after general anesthesia using visual analogue scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haitong Liu | Zhenjiang First People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhenjiang First People's Hospital | Zhenjiang | Jiangsu | 212002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28854538 | Background | 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. | |
| 28854543 | Background |
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all collected IPD, all IPD that underlie results in a publication
Data are available after publication and up to one year after publication.
Send an email to dolinet@163.com
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Normal saline | Drug | normal saline |
|
|
| Midazolam | Drug | midazolam |
|
|
Pain changes after general anesthesia using visual analogue scale(0 to 10,higher scores mean a worse outcome) in each group |
| before general anesthesia, up to 2 hours after general anesthesia |
| 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. |
| 26005187 | Background | 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. |
| 26991622 | Background | 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. |
| 29742525 | Background | 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. |
| 26559412 | Background | 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. |
| 29528863 | Background | 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. |
| 10702460 | Background | 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. |
| 29680809 | Background | 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. |
| 28105598 | Background | 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. |
| 23524149 | Background | 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. |
| 37291651 | Derived | 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. |
| D007869 |
| Leg Injuries |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |