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Safety and efficacy evaluation of intraoperative low-dose esmketamine hydrochloride injection for postoperative delirium in frail elderly patients undergoing hip arthroplasty: a single-center, prospective, randomized, single-blind, parallel controlled clinical trial

Safety and efficacy evaluation of intraoperative low-dose esmketamine hydrochloride injection for postoperative delirium in frail elderly patients undergoing hip arthroplasty: a single-center, prospective, randomized, single-blind, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092310
Enrollment
Unknown
Registered
2024-11-14
Start date
2024-11-18
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fractures

Interventions

esmketamine group:After combined spinal-epidural anesthesia, administer a loading dose of esketamine of 0.125 mg/kg before the surgical incision, followed by a continuous infusion of 0.1 mg/kg/h until
control group:Equal dose of physiological saline

Sponsors

Shiyan Taihe Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 65 years, regardless of gender; 2.CFS score >= 5 points; 3.Planned elective hip joint replacement surgery under combined spinal-epidural anesthesia; 4.Voluntarily signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Individuals who are allergic to the active ingredients or excipients of ketamine hydrochloride injection; 2.Patients with severe consciousness disorders or mental system diseases (such as schizophrenia, mania, bipolar disorder, psychosis, etc.) and cognitive dysfunction; 3.Individuals with a history of severe cardiovascular disease (such as congestive heart failure, severe angina attacks, or unstable angina or myocardial infarction within the past 6 months); 4.Patients with an MMSE score of < 18; 5.Patients with any contraindications for the use of ketamine hydrochloride injection: a) Patients at serious risk of elevated blood pressure or intracranial pressure; b) Patients with high intraocular pressure (glaucoma) or penetrating eye trauma; c) Patients with uncontrolled or untreated hypertension (arterial hypertension, resting systolic blood pressure exceeding 180mmHg, or resting diastolic blood pressure exceeding 100mmHg); d) Untreated or inadequately treated patients with hyperthyroidism; e) Patients with a family history of malignant hyperthermia or a high risk of malignant hyperthermia (such as strabismus, scoliosis, etc.).

Design outcomes

Primary

MeasureTime frame
Postoperative Delirium;

Secondary

MeasureTime frame
NRS Pain Score;The time from the end of surgery to the first use of salvage analgesics after surgery;Opioid consumption within 48 hours after surgery;Incidence of intraoperative adverse events;Evaluation of Patient Efficacy Questionnaire (IPOQ Scale) 48 Hours After Surgery;Incidence of postoperative adverse events;Postoperative cognitive function ;Postoperative anxiety and depression ;

Countries

China

Contacts

Public ContactLuo Xianghong

Shiyan Taihe Hospital

doctorll2020@163.com+86 139 9782 8295

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026