A Study of the Correlation Between the Debilitating State of the Elderly and Propofol Sensitivity

NCT06870357 | Completed Early Phase 1

• 1 other identifier: yuewei20240110
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

In an aging society, there is a surge in the number of surgeries for elderly patients in hospitals, and the elderly are at greater risk of anesthesia due to their own characteristics: slowing metabolism, decreasing resistance, and decreasing physical function, and increased sensitivity to propofol. However, there are large individual differences, and anesthesiologists have found that they cannot judge a patient's sensitivity to anesthetic drugs based on age alone. Patients with different levels of debilitation have different sensitivities to propofol. The use of measuring telomere length to assess the debilitating state of the elderly is a novel and reliable assessment method. Then the sensitivity to propofol of people with different debilitating states was studied, so as to guide anesthesiologists to use drugs safely and reasonably, with a view to realizing the purpose of precise anesthesia.

Conditions

Frailty; Telomere

Keywords

telomere length; propofol; Frailty

Outcome Measures

Primary Outcomes (8)

• telomere length

  Differences in telomere length

  24 hours

• Loss of consciousness time

  Differences in loss of consciousness time

  24 hours

• awakening time

  Differences in awakening time

  24 hours

• Propofol dosage

  Differences in Propofol dosage

  24 hours

• Mean Arterial Pressure (MAP)

  Differences in Mean Arterial Pressure (MAP)

  24 hours

• heart rate

  Differences in heart rate

  24 hours

• Electroencephalographic dual frequency index (BIS value)

  Differences in Electroencephalographic dual frequency index (BIS value)

  24 hours

• Incidence of adverse effects (hypotension, bradycardia, respiratory depression)

  Incidence of adverse effects (hypotension, bradycardia, respiratory depression)

  24 hours

Secondary Outcomes (1)

• Use of vasoactive drugs

  24 hours

Other Outcomes (2)

• Checklist form: Sex, age, ASA classification, smoking history, drinking history, comorbidities

  24 hours

• BMI

  24 hours

Study Arms (2)

frail group

EXPERIMENTAL

Edmonton scores three or more points

Drug: propofol

non-frail group

EXPERIMENTAL

Edmonton scores zero to three

Drug: propofol

Interventions

propofol DRUG

Fifteen minutes after the subarachnoid block, propofol was pumped in at a rate of 20 mg/kg/h with a micro pump, and the pumping rate was reduced to 10 mg/kg/h after 1 min. The infusion was stopped when the consciousness disappeared, and the time of the disappearance of consciousness was observed (time of the disappearance of eyelash reflex).

Also known as: Ropivacaine

frail group; non-frail group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 65 years
• American Society of Anesthesiologists (ASA) Classification I-IV
• No previous history of central nervous system disease, no history of psychiatric disorders, no contraindications to anesthesia
• No use of sedative drugs or opioids within 24h
• Approval and consent by the Ethics Committee of Shanxi Medical University and written informed consent by the patient (or authorized delegate)

You may not qualify if:

• leukemia patient
• Patients with hearing and visual impairments, communication disorders, inability to complete the debilitating state test
• Patient or family refused to participate in this study

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Conditions

Frailty

Interventions

Propofol; Ropivacaine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: March 11, 2025
• Study Start: January 20, 2024
• Primary Completion: June 20, 2024
• Study Completion: October 20, 2024
• Last Updated: March 11, 2025

Record last verified: 2024-01

Locations

CN (1)