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

NCT06046638 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-21

No results posted yet for this study

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

Interventions

DRUG

Cyclopofol

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

DRUG

Propofol

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

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

  • Haisco Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-12-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06046638 on ClinicalTrials.gov