Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

Hip Fractures Clinical Trial

Official title:

Effects of Dexmedetomidine at Different Doses on Hemodynamics and Recovery Quality in Elderly Patients Undergoing Hip Replacement Surgery Under General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567523
• Other study ID #: SQK-20190131-W
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: October 2022
• Source: Zhenjiang First People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• age =65yr, American Society of Anesthesiologists (ASA) physical status scale grade I-III, ready for HP; body weight between 45 and 75kg, body mass index (BMI) between 18 and 24kg/m2;
• 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:

• Age <65 yr or >90 yr; BMI greater than 24 kg/m2; ASA grade higher than III;
• 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.

Related Conditions & MeSH terms

• Hip Disease
• Hip Fractures

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Zhenjiang First People's Hospital	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhenjiang First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes of baseline heart rate	Changes of baseline heart rate in each group	Through the whole perioperative period, an average of 10 hours
Primary	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
Primary	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
Secondary	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
Secondary	Pain changes after general anesthesia using visual analogue scale	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