FrailtyEarly Phase 1NCT06870357
A Study of the Correlation Between the Debilitating State of the Elderly and Propofol Sensitivity
A Early Phase 1 study testing propofol in people with Frailty and Telomere, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 20 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
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.
Read the detailed description
Part I: A study of the correlation between telomere length and somatic debilitation status in older adults Telomere length was measured by fluorescent quantitative PCR, and subjects were assessed for somatic frailty using the Edmonton Scale (EFS).
- Perform a correlation analysis between telomere length and Edmonton debility score.
- Comparison of telomere length differences between Edmonton debility subgroups.
- Subjects were categorized into "not debilitated" and "debilitated" dichotomous variables according to Edmonton debilitation ratings. The strength of the predictive power of telomere length for frailty was determined using the area under the ROC curve (AUC) using the operator operating characteristic curve ROC treatment .
Part II: Correlation between telomere length and propofol sensitivity in elderly surgical patients A total of 128 patients undergoing lower limb surgery under subarachnoid block in the Second Hospital of Shanxi Medical University were selected and divided into non-frailty group and frailty group.Propofol was pumped at a rate of 20 mg/kg/h with a micropump at 15 minutes after subarachnoid block, and the pumping rate was reduced to 10 mg/kg/h after 1 minute.Stop the infusion when consciousness is absent and observe the time of loss of consciousness (time of loss of eyelash reflex).
intraoperative recording of the time of loss of consciousness (time of disappearance of eyelash reflex), time of awakening, and dosage of propofol in both groups; recording of the time of admission to the room (T0), the time after completion of subarachnoid blockade (T1), the time after 1min of pumping propofol (T2), the time after 5min of pumping propofol (T3), the time after 10min of pumping propofol (T4), the time after 15min of pumping propofol ( T5), after pumping propofol for 20 min (T6), after pumping propofol for 25 min (T7), and after pumping propofol for 30 min (T8); mean arterial pressure (MAP), heart rate (HR), and electroencephalographic dual-frequency index (BIS value) at nine time points; the incidence of adverse reactions (hypotension, bradycardia, and respiratory depression) was recorded for the two groups.
Research hypotheses:
- There is a difference in propofol sensitivity indices between the debilitated and non-debilitated groups. [time to loss of consciousness; heart rate; MAP; BIS; occurrence of adverse effects; use of vasoactive drugs].
- There was a difference in telomere length between the debilitated and non-debilitated groups.
- Among all patients, those with shorter telomere lengths were more sensitive to propofol, and the patients' sensitivity to propofol could be predicted by their telomere lengths. experimental procedure
- Comparison of demographic information between the two groups
- Comparison of propofol sensitivity between the two groups
- Comparison of telomere length between the two groups.
- To analyze the correlation between telomere length and its demographic and clinical characteristics for the two groups, the multiple linear regression model was further used to analyze the factors associated with telomere length for all patients, taking the independent variables of gender, age, BMI and other demographic information, and the dependent variable of telomere length. Again, it is shown that there is no significant linear relationship between patients' demographic information and telomere length. Then explain how factors that have a linear correlation will affect the patient's sensitivity to propofol.
- Analyze the correlation between telomere length and propofol sensitivity indexes, and then use linear regression model to further regress telomere length on the indexes with correlation. The independent variable was selected as telomere length and the dependent variable was time to loss of consciousness/heart rate/MAP/BIS. the model was subjected to analysis of variance (ANOVA) to obtain the β and P values, which indicated whether the model was statistically significant and whether the telomere length could predict several of the above indexes.
- Being tested
- propofol
- Keywords
- telomere length, propofol, Frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Ropivacaine
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).
| Study group | Role | What they receive |
|---|---|---|
| frail group | Experimental | Edmonton scores three or more points Receives: Drug: propofol |
| non-frail group | Experimental | Edmonton scores zero to three Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
telomere length
Differences in telomere length
Measured: 24 hours
Loss of consciousness time
Differences in loss of consciousness time
Measured: 24 hours
awakening time
Differences in awakening time
Measured: 24 hours
Propofol dosage
Differences in Propofol dosage
Measured: 24 hours
Mean Arterial Pressure (MAP)
Differences in Mean Arterial Pressure (MAP)
Measured: 24 hours
heart rate
Differences in heart rate
Measured: 24 hours
Electroencephalographic dual frequency index (BIS value)
Differences in Electroencephalographic dual frequency index (BIS value)
Measured: 24 hours
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
Measured: 24 hours
Secondary outcomes (1)
Use of vasoactive drugs
Use of vasoactive drugs
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start20 Jan 2024
- Primary completion20 Jun 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870357
- Sponsor's protocol ID
- yuewei20240110
- Status last verified
- Jan 2024
- First submitted
- 19 Nov 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Correlation Between the Debilitating State of the Elderly and Propofol Sensitivity
- ClinicalTrials.gov ID
- NCT06870357
- Acronym / sponsor ID
- yuewei20240110
- Keywords
- telomere length, propofol, Frailty
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part I: A study of the correlation between telomere length and somatic debilitation status in older adults Telomere length was measured by fluorescent quantitative PCR, and subjects were assessed for somatic frailty using the Edmonton Scale (EFS).
- Perform a correlation analysis between telomere length and Edmonton debility score.
- Comparison of telomere length differences between Edmonton debility subgroups.
- Subjects were categorized into "not debilitated" and "debilitated" dichotomous variables according to Edmonton debilitation ratings. The strength of the predictive power of telomere length for frailty was determined using the area under the ROC curve (AUC) using the operator operating characteristic curve ROC treatment .
Part II: Correlation between telomere length and propofol sensitivity in elderly surgical patients A total of 128 patients undergoing lower limb surgery under subarachnoid block in the Second Hospital of Shanxi Medical University were selected and divided into non-frailty group and frailty group.Propofol was pumped at a rate of 20 mg/kg/h with a micropump at 15 minutes after subarachnoid block, and the pumping rate was reduced to 10 mg/kg/h after 1 minute.Stop the infusion when consciousness is absent and observe the time of loss of consciousness (time of loss of eyelash reflex).
intraoperative recording of the time of loss of consciousness (time of disappearance of eyelash reflex), time of awakening, and dosage of propofol in both groups; recording of the time of admission to the room (T0), the time after completion of subarachnoid blockade (T1), the time after 1min of pumping propofol (T2), the time after 5min of pumping propofol (T3), the time after 10min of pumping propofol (T4), the time after 15min of pumping propofol ( T5), after pumping propofol for 20 min (T6), after pumping propofol for 25 min (T7), and after pumping propofol for 30 min (T8); mean arterial pressure (MAP), heart rate (HR), and electroencephalographic dual-frequency index (BIS value) at nine time points; the incidence of adverse reactions (hypotension, bradycardia, and respiratory depression) was recorded for the two groups.
Research hypotheses:
- There is a difference in propofol sensitivity indices between the debilitated and non-debilitated groups. [time to loss of consciousness; heart rate; MAP; BIS; occurrence of adverse effects; use of vasoactive drugs].
- There was a difference in telomere length between the debilitated and non-debilitated groups.
- Among all patients, those with shorter telomere lengths were more sensitive to propofol, and the patients' sensitivity to propofol could be predicted by their telomere lengths. experimental procedure
- Comparison of demographic information between the two groups
- Comparison of propofol sensitivity between the two groups
- Comparison of telomere length between the two groups.
- To analyze the correlation between telomere length and its demographic and clinical characteristics for the two groups, the multiple linear regression model was further used to analyze the factors associated with telomere length for all patients, taking the independent variables of gender, age, BMI and other demographic information, and the dependent variable of telomere length. Again, it is shown that there is no significant linear relationship between patients' demographic information and telomere length. Then explain how factors that have a linear correlation will affect the patient's sensitivity to propofol.
- Analyze the correlation between telomere length and propofol sensitivity indexes, and then use linear regression model to further regress telomere length on the indexes with correlation. The independent variable was selected as telomere length and the dependent variable was time to loss of consciousness/heart rate/MAP/BIS. the model was subjected to analysis of variance (ANOVA) to obtain the β and P values, which indicated whether the model was statistically significant and whether the telomere length could predict several of the above indexes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frail group | Experimental | Drug: propofolEdmonton scores three or more points |
| non-frail group | Experimental | Drug: propofolEdmonton scores zero to three |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: RopivacaineFifteen 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). | Drug | frail group, non-frail group |
Primary outcome
telomere length
Time frame: 24 hours
Differences in telomere length
Loss of consciousness time
Time frame: 24 hours
Differences in loss of consciousness time
awakening time
Time frame: 24 hours
Differences in awakening time
Propofol dosage
Time frame: 24 hours
Differences in Propofol dosage
Mean Arterial Pressure (MAP)
Time frame: 24 hours
Differences in Mean Arterial Pressure (MAP)
heart rate
Time frame: 24 hours
Differences in heart rate
Electroencephalographic dual frequency index (BIS value)
Time frame: 24 hours
Differences in Electroencephalographic dual frequency index (BIS value)
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
Time frame: 24 hours
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
1 secondary outcome
Use of vasoactive drugs
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing propofol in people with Frailty and Telomere, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
telomere length (time frame: 24 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.