Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

NCT05567523 | Completed Phase 4

• 1 other identifier: SQK-20190131-W
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Fractures; Hip Disease

Keywords

Dexmedetomidine; Elderly; Hemodynamics; Hip replacement; General anesthesia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Sedation changes after general anesthesia using Richmond agitation-sedation scale

  before general anesthesia, up to 2 hours after general anesthesia

• Pain changes after general anesthesia using visual analogue scale

  before general anesthesia, up to 2 hours after general anesthesia

Study Arms (2)

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.

Drug: Dexmedetomidine

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.

Drug: Normal saline; Drug: Midazolam

Interventions

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.

Also known as: Dex

Group D0.25, Group D0.5, Group D0.75

Normal saline DRUG

normal saline

Also known as: physiological saline

Group NS, Group MD

Midazolam DRUG

midazolam

Also known as: Dormicum

Group NS, Group MD

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhenjiang First People's Hospital: lead

Study Sites (1)

Zhenjiang First People's Hospital

Zhenjiang, Jiangsu, 212002, China

Location

Related Publications (12)

• 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.

  PMID: 28854538 BACKGROUND

• 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.

  PMID: 28854543 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.

  PMID: 26005187 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.

  PMID: 26991622 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.

  PMID: 29742525 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.

  PMID: 26559412 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.

  PMID: 29528863 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.

  PMID: 10702460 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.

  PMID: 29680809 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.

  PMID: 28105598 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.

  PMID: 23524149 BACKGROUND

• 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.

  PMID: 37291651 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Dexmedetomidine; Saline Solution; Midazolam

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Haitong Liu

  Zhenjiang First People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 5, 2022
• Study Start: June 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: March 30, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data are available after publication and up to one year after publication.
• Access Criteria: Send an email to dolinet@163.com

Locations

CN (1)