Cyclopofol Versus Propofol for Postoperative Delirium in Elderly Patients Having Orthopedic Surgery

NCT06046638 | Unknown Phase 4

• 1 other identifier: LY2022-087-B
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative delirium (POD) is common in elderly patients recovering from surgery and anesthesia. POD has adverse effects on early and long-term prognosis. The incidence of POD increases with age and patients with preoperative cognitive changes or coexisting diseases. The bispectral index (BIS) is an electroencephalographic measurement commonly used to monitor the depth of anesthesia. Low intraoperative BIS value (BIS\<40) and prolonged duration of low BIS value maybe risk factors of POD. A small sub-study of BALANCED Anaesthesia Study demonstrated a protective effect of targeting a BIS of 50 to reduce POD compared with a BIS of 35. The stability of BIS during general anesthesia may affect the risk of POD in elderly patients. Therefore, it is very important to maintain a stable BIS value as much as possible during general anesthesia surgery, and a general anesthetic with good BIS stability is even more needed in clinical practice. Cyclopofol is a new type of anesthetic/sedative that reportedly provides good efficacy and safety. Cyclopofol has a more stable effect on BIS, so whether the use of cyclopofol in elderly patients undergoing orthopedic surgery can reduce the occurrence of POD, improve prognosis, and exert a brain protective effect will be of great importance and clinical research value.

Conditions

Postoperative Delirium; Stroke

Keywords

Cyclopofol; Propofol; Postoperative Delirium; Stroke; Orthopedic Surgery; Elderly Patients

Outcome Measures

Primary Outcomes (1)

• Incidence of POD within 3 days after surgery (3D-CAM)

  Incidence of POD will be assessed at baseline and once daily within 3 days after surgery (3D-CAM) by anesthesiologist(s).

  72 hours post surgery

Secondary Outcomes (17)

• Incidence of POD within 3 days after surgery (CAM-ICU)

  72 hours post surgery

• Low BIS level

  During surgery

• Duration of low BIS level

  During surgery

• Cerebral oxygen metabolism index

  During surgery

• Cerebral oxygen saturation

  During surgery

Study Arms (2)

Cyclopofol

EXPERIMENTAL

For patients in the cyclopofol group, cyclopofol will be given as induction of anesthesia (0.4 mg/kg) followed by a continuous infusion (0.8 mg/kg/h) until the end of surgery.

Drug: Cyclopofol

Propofol

ACTIVE COMPARATOR

For patients in the propofol group, propofol will be given as induction of anesthesia (2 mg/kg) followed by a continuous infusion (5 mg/kg/h) until the end of surgery.

Drug: Propofol

Interventions

Cyclopofol DRUG

Induction of anesthesia followed by continuous infusion through out surgery. The anesthetic drug regimen will be adjusted according to the changes of blood pressure.

Also known as: Haisco Pharmaceutical Group Co., Ltd

Cyclopofol

Propofol DRUG

Induction of anesthesia followed by continuous infusion through out surgery. The anesthetic drug regimen will be adjusted according to the changes of blood pressure.

Also known as: Fresenius Kabi Austria GmbH

Propofol

Eligibility Criteria

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

You may qualify if:

• Age 65 to 90 years old (including the critical value), male or female;
• Scheduled to undergo orthopaedic surgery under general anesthesia, including femoral surgery, hip surgery, lumbar spine surgery, and do not plan to enter the ICU after surgery;
• ASA II-III;
• Preoperative mild cognitive function changes (MMSE score 21-26);
• Multiple coexisting diseases (at least one or more), including history of stroke (at least 6 months before elective surgery), hypertension, diabetes, ischemic heart disease, chronic obstructive pulmonary disease, obstructive sleep apnea, chronic kidney disease, hypoalbuminemia, anemia, water electricity and acid-base disorders;
• The expected hospital stay is at least 2 days;
• Agree to participate and give written informed consent.

You may not qualify if:

• Patients with preoperative delirium (3D-CAM positive);
• Patients with severe cognitive impairment (MMSE score \<15);
• Patients with history of psychological and nervous system diseases (such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc.) that interfere with the judgment of curative effect indicators disease factors;
• Patients with severe congestive heart failure (New York Heart Association, class IV) or severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV);
• The surgical site interferes with the placement of BIS electrodes;
• Mental or language barriers impede data collection; Other reasons (such as hearing impairment or visual impairment) could not complete the MMSE, MoCA scales.

Sponsors & Collaborators

• RenJi Hospital: lead
• Haisco Pharmaceutical Group Co., Ltd.: collaborator

MeSH Terms

Conditions

Emergence Delirium; Stroke

Interventions

Long-Term Synaptic Depression; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09