General AnesthesiaNCT03429309
The Association Between Telomere Length and Propofol Dose in Anesthesia-induction
A study testing Propofol in people with General Anesthesia, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
Telomeres are protein-bound DNA repeat structures at the end of eukaryotic chromosomes that are made up of a simple repetitive sequence (in humans, TTAGGG) and regulate cellular replicative capacity and cellular proliferation, protect chromosomes from fusing together during mitosis and maintain genomic stability, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Anesthesia
- 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 28 Feb 2018
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were scheduled for elective surgical procedures
Who cannot join
- patients with known cardiac, pulmonary, renal disease, hearing disorders or neurological diseases, diabetes, and patients taking drugs affecting to the central nervous system or consuming more than 20 g alcohol daily, a body mass index>30
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
Weifeng Tu, PhD, +8613922116606, wftuyx02@163.com
About this study
Official title: The Association Between Telomere Length in Peripheral Blood Leukocyte and Propofol Dose in Anesthesia-induction
Telomeres are protein-bound DNA repeat structures at the end of eukaryotic chromosomes that are made up of a simple repetitive sequence (in humans, TTAGGG) and regulate cellular replicative capacity and cellular proliferation, protect chromosomes from fusing together during mitosis and maintain genomic stability, and prevent the loss of genetic data. Telomeres are specialized repetitive DNA sequences, typically ranging from 5,000 to 15,000 bp in humans, which are the critical chromosome capping DNA sequences. The loss of telomere repeats diminishes telomeric functional capacity.Telomere length(TL) is important in determining telomere function.This is known as the end replication problem and results in a gradual decline in TL over time. Consequently,leukocyte TL shortens in a predictable way with age by roughly 20-40 base pairs per year. Cellular senescence and subsequent cell death often occur when the mean telomere length reaches a critical value.Shortened telomeres and lower telomerase are linked to age-related risk factors and disease.Peripheral blood leukocyte express telomerase at low levels, which can be measured over a short duration (hours) to demonstrate immediate, short-term changes. Shorter mean leukocyte telomere length has been shown to be associated with risk of several age-related diseases.The dosage of propofol gradually reduced with the aging process. However,it is not known whether the telomere length and variation of telomerase in PBL relate to the dosage of propofol and time of consciousness disappearance in anesthesia induction. In this exploratory study, the investigators examined that the changes of peripheral blood leukocyte telomere length was associated with the dosage of propofol and time of consciousness disappearance in anesthesia induction.
Given the importance of telomeres in nuclear and cellular function, the central role of telomere length in determining telomere function,the investigator study that the changes of telomere length in peripheral blood leukocyte of patients are associated with the dosage of propofol in anesthesia induction.
Read the detailed description
A hundred patients with the American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 80 years, gave an informed-written consent to participate.Testing took place in the morning after an overnight fast. Patients were scheduled for elective surgical procedures. After arrival to the operating theater, the peripheral venous line for fluid and drug administration was inserted. The electrocardiogram, heart rate, a noninvasive blood pressure, a pulse oximeter and bispectral (BIS) Index were monitored continuously. 100% oxygen was given for 3 min by face mask. Anesthesia was induced by intravenous infusion of propofol via the syringe pump at a rate of 30 mg/kg/h. Recordings began before propofol induction started. After the start of the propofol infusion and BIS Index at 80, patients were asked loudly "open eyes" and examined eyelash reflex at 15-s intervals until loss of consciousness (unresponsiveness to the verbal command, no spontaneous movements and loss of eyelash reflex); and recordings of the heart rate, a noninvasive blood pressure and BIS Index were obtained during awake baseline and unconsciousness induced by propofol. Propofol dosage and consciousness disappearance time were recorded after propofol-induced loss of consciousness. The commands were spoken in a loud voice by the investigator and were repeated up to three times, if the subject failed to respond. A subject who obeyed command was considered conscious. The BIS index is useful, and a reliable and sensitive indicator for assessing the level of consciousness during sedation and hypnosis with propofol so that the investigators recorded BIS index to evaluate level of consciousness. To minimize artifacts, patients were instructed not to open their eyes, talk, or move during the heart rate, a noninvasive blood pressure and BIS Index recordings before the propofol infusion and the sedation level was assessed until the patient's unconsciousness.
- Conditions
- General Anesthesia
- Being tested
- Propofol
- Keywords
- telomere, propofol, anesthesia-induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Anesthesia was induced by intravenous infusion of propofol via the syringe pump at a rate of 30 mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia-induction with propofol | Other | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol Dose
Dosage of propofol in anesthesia-induction.
Measured: through study completion, up to 6 months
Telomere Length
Telomere length of peripheral blood leukocyte
Measured: through study completion, up to 6 months
Secondary outcomes (4)
Time of anesthesia-induction.
Time counted from the beginning of anesthesia-induction to patient consciousness disappearance.
Measured: through study completion, up to 6 months
HR
Heart Rate
Measured: through study completion, up to 6 months
BP
Blood Pressure
Measured: through study completion, up to 6 months
BIS
BIS index
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Dec 2017
- Primary completion1 Feb 2018
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429309
- Sponsor's protocol ID
- Telomere length and propofol
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blackburn EH, Greider CW, Szostak JW. Telomeres and telomerase: the path from maize, Tetrahymena and yeast to human cancer and aging. Nat Med. 2006 Oct;12(10):1133-8. doi: 10.1038/nm1006-1133. No abstract available.
PubMed 17024208Aubert G, Lansdorp PM. Telomeres and aging. Physiol Rev. 2008 Apr;88(2):557-79. doi: 10.1152/physrev.00026.2007.
PubMed 18391173Biegler KA, Anderson AK, Wenzel LB, Osann K, Nelson EL. Longitudinal change in telomere length and the chronic stress response in a randomized pilot biobehavioral clinical study: implications for cancer prevention. Cancer Prev Res (Phila). 2012 Oct;5(10):1173-82. doi: 10.1158/1940-6207.CAPR-12-0008. Epub 2012 Jul 24.
PubMed 22827974Starkweather AR, Alhaeeri AA, Montpetit A, Brumelle J, Filler K, Montpetit M, Mohanraj L, Lyon DE, Jackson-Cook CK. An integrative review of factors associated with telomere length and implications for biobehavioral research. Nurs Res. 2014 Jan-Feb;63(1):36-50. doi: 10.1097/NNR.0000000000000009.
PubMed 24335912Munoz P, Blanco R, Blasco MA. Role of the TRF2 telomeric protein in cancer and ageing. Cell Cycle. 2006 Apr;5(7):718-21. doi: 10.4161/cc.5.7.2636. Epub 2006 Apr 1.
PubMed 16582635Codd V, Mangino M, van der Harst P, Braund PS, Kaiser M, Beveridge AJ, Rafelt S, Moore J, Nelson C, Soranzo N, Zhai G, Valdes AM, Blackburn H, Mateo Leach I, de Boer RA, Kimura M, Aviv A; Wellcome Trust Case Control Consortium; Goodall AH, Ouwehand W, van Veldhuisen DJ, van Gilst WH, Navis G, Burton PR, Tobin MD, Hall AS, Thompson JR, Spector T, Samani NJ. Common variants near TERC are associated with mean telomere length. Nat Genet. 2010 Mar;42(3):197-9. doi: 10.1038/ng.532. Epub 2010 Feb 7.
PubMed 20139977Cesare AJ, Reddel RR. Alternative lengthening of telomeres: models, mechanisms and implications. Nat Rev Genet. 2010 May;11(5):319-30. doi: 10.1038/nrg2763. Epub 2010 Mar 30.
PubMed 20351727Capezzone M, Cantara S, Marchisotta S, Filetti S, De Santi MM, Rossi B, Ronga G, Durante C, Pacini F. Short telomeres, telomerase reverse transcriptase gene amplification, and increased telomerase activity in the blood of familial papillary thyroid cancer patients. J Clin Endocrinol Metab. 2008 Oct;93(10):3950-7. doi: 10.1210/jc.2008-0372. Epub 2008 Jul 29.
PubMed 18664542Epel ES, Lin J, Dhabhar FS, Wolkowitz OM, Puterman E, Karan L, Blackburn EH. Dynamics of telomerase activity in response to acute psychological stress. Brain Behav Immun. 2010 May;24(4):531-9. doi: 10.1016/j.bbi.2009.11.018. Epub 2009 Dec 16.
PubMed 20018236Humphreys J, Epel ES, Cooper BA, Lin J, Blackburn EH, Lee KA. Telomere shortening in formerly abused and never abused women. Biol Res Nurs. 2012 Apr;14(2):115-23. doi: 10.1177/1099800411398479. Epub 2011 Mar 8.
PubMed 21385798
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Telomere Length in Peripheral Blood Leukocyte and Propofol Dose in Anesthesia-induction
- ClinicalTrials.gov ID
- NCT03429309
- Acronym / sponsor ID
- Telomere length and propofol
- Conditions
- General Anesthesia
- Keywords
- telomere, propofol, anesthesia-induction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 12 Feb 2018 (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.
Telomeres are protein-bound DNA repeat structures at the end of eukaryotic chromosomes that are made up of a simple repetitive sequence (in humans, TTAGGG) and regulate cellular replicative capacity and cellular proliferation, protect chromosomes from fusing together during mitosis and maintain genomic stability, and prevent the loss of genetic data. Telomeres are specialized repetitive DNA sequences, typically ranging from 5,000 to 15,000 bp in humans, which are the critical chromosome capping DNA sequences. The loss of telomere repeats diminishes telomeric functional capacity.Telomere length(TL) is important in determining telomere function.This is known as the end replication problem and results in a gradual decline in TL over time. Consequently,leukocyte TL shortens in a predictable way with age by roughly 20-40 base pairs per year. Cellular senescence and subsequent cell death often occur when the mean telomere length reaches a critical value.Shortened telomeres and lower telomerase are linked to age-related risk factors and disease.Peripheral blood leukocyte express telomerase at low levels, which can be measured over a short duration (hours) to demonstrate immediate, short-term changes. Shorter mean leukocyte telomere length has been shown to be associated with risk of several age-related diseases.The dosage of propofol gradually reduced with the aging process. However,it is not known whether the telomere length and variation of telomerase in PBL relate to the dosage of propofol and time of consciousness disappearance in anesthesia induction. In this exploratory study, the investigators examined that the changes of peripheral blood leukocyte telomere length was associated with the dosage of propofol and time of consciousness disappearance in anesthesia induction.
Given the importance of telomeres in nuclear and cellular function, the central role of telomere length in determining telomere function,the investigator study that the changes of telomere length in peripheral blood leukocyte of patients are associated with the dosage of propofol in anesthesia induction.
Detailed description
A hundred patients with the American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 80 years, gave an informed-written consent to participate.Testing took place in the morning after an overnight fast. Patients were scheduled for elective surgical procedures. After arrival to the operating theater, the peripheral venous line for fluid and drug administration was inserted. The electrocardiogram, heart rate, a noninvasive blood pressure, a pulse oximeter and bispectral (BIS) Index were monitored continuously. 100% oxygen was given for 3 min by face mask. Anesthesia was induced by intravenous infusion of propofol via the syringe pump at a rate of 30 mg/kg/h. Recordings began before propofol induction started. After the start of the propofol infusion and BIS Index at 80, patients were asked loudly "open eyes" and examined eyelash reflex at 15-s intervals until loss of consciousness (unresponsiveness to the verbal command, no spontaneous movements and loss of eyelash reflex); and recordings of the heart rate, a noninvasive blood pressure and BIS Index were obtained during awake baseline and unconsciousness induced by propofol. Propofol dosage and consciousness disappearance time were recorded after propofol-induced loss of consciousness. The commands were spoken in a loud voice by the investigator and were repeated up to three times, if the subject failed to respond. A subject who obeyed command was considered conscious. The BIS index is useful, and a reliable and sensitive indicator for assessing the level of consciousness during sedation and hypnosis with propofol so that the investigators recorded BIS index to evaluate level of consciousness. To minimize artifacts, patients were instructed not to open their eyes, talk, or move during the heart rate, a noninvasive blood pressure and BIS Index recordings before the propofol infusion and the sedation level was assessed until the patient's unconsciousness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia-induction with propofol | Other | Drug: Propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were scheduled for elective surgical procedures
Key exclusion criteria (1 listed)
- patients with known cardiac, pulmonary, renal disease, hearing disorders or neurological diseases, diabetes, and patients taking drugs affecting to the central nervous system or consuming more than 20 g alcohol daily, a body mass index>30
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 |
|---|---|---|
| PropofolAnesthesia was induced by intravenous infusion of propofol via the syringe pump at a rate of 30 mg/kg/h. | Drug | Anesthesia-induction with propofol |
Primary outcome
Propofol Dose
Time frame: through study completion, up to 6 months
Dosage of propofol in anesthesia-induction.
Telomere Length
Time frame: through study completion, up to 6 months
Telomere length of peripheral blood leukocyte
4 secondary outcomes
Time of anesthesia-induction.
Time frame: through study completion, up to 6 months
HR
Time frame: through study completion, up to 6 months
BP
Time frame: through study completion, up to 6 months
BIS
Time frame: through study completion, up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Background: PubMed 17024208Blackburn EH, Greider CW, Szostak JW. Telomeres and telomerase: the path from maize, Tetrahymena and yeast to human cancer and aging. Nat Med. 2006 Oct;12(10):1133-8. doi: 10.1038/nm1006-1133. No abstract available.
- Background: PubMed 18391173Aubert G, Lansdorp PM. Telomeres and aging. Physiol Rev. 2008 Apr;88(2):557-79. doi: 10.1152/physrev.00026.2007.
- Background: PubMed 22827974Biegler KA, Anderson AK, Wenzel LB, Osann K, Nelson EL. Longitudinal change in telomere length and the chronic stress response in a randomized pilot biobehavioral clinical study: implications for cancer prevention. Cancer Prev Res (Phila). 2012 Oct;5(10):1173-82. doi: 10.1158/1940-6207.CAPR-12-0008. Epub 2012 Jul 24.
- Background: PubMed 24335912Starkweather AR, Alhaeeri AA, Montpetit A, Brumelle J, Filler K, Montpetit M, Mohanraj L, Lyon DE, Jackson-Cook CK. An integrative review of factors associated with telomere length and implications for biobehavioral research. Nurs Res. 2014 Jan-Feb;63(1):36-50. doi: 10.1097/NNR.0000000000000009.
- Background: PubMed 16582635Munoz P, Blanco R, Blasco MA. Role of the TRF2 telomeric protein in cancer and ageing. Cell Cycle. 2006 Apr;5(7):718-21. doi: 10.4161/cc.5.7.2636. Epub 2006 Apr 1.
- Background: PubMed 20139977Codd V, Mangino M, van der Harst P, Braund PS, Kaiser M, Beveridge AJ, Rafelt S, Moore J, Nelson C, Soranzo N, Zhai G, Valdes AM, Blackburn H, Mateo Leach I, de Boer RA, Kimura M, Aviv A; Wellcome Trust Case Control Consortium; Goodall AH, Ouwehand W, van Veldhuisen DJ, van Gilst WH, Navis G, Burton PR, Tobin MD, Hall AS, Thompson JR, Spector T, Samani NJ. Common variants near TERC are associated with mean telomere length. Nat Genet. 2010 Mar;42(3):197-9. doi: 10.1038/ng.532. Epub 2010 Feb 7.
- Background: PubMed 20351727Cesare AJ, Reddel RR. Alternative lengthening of telomeres: models, mechanisms and implications. Nat Rev Genet. 2010 May;11(5):319-30. doi: 10.1038/nrg2763. Epub 2010 Mar 30.
- Background: PubMed 18664542Capezzone M, Cantara S, Marchisotta S, Filetti S, De Santi MM, Rossi B, Ronga G, Durante C, Pacini F. Short telomeres, telomerase reverse transcriptase gene amplification, and increased telomerase activity in the blood of familial papillary thyroid cancer patients. J Clin Endocrinol Metab. 2008 Oct;93(10):3950-7. doi: 10.1210/jc.2008-0372. Epub 2008 Jul 29.
- Background: PubMed 20018236Epel ES, Lin J, Dhabhar FS, Wolkowitz OM, Puterman E, Karan L, Blackburn EH. Dynamics of telomerase activity in response to acute psychological stress. Brain Behav Immun. 2010 May;24(4):531-9. doi: 10.1016/j.bbi.2009.11.018. Epub 2009 Dec 16.
- Background: PubMed 21385798Humphreys J, Epel ES, Cooper BA, Lin J, Blackburn EH, Lee KA. Telomere shortening in formerly abused and never abused women. Biol Res Nurs. 2012 Apr;14(2):115-23. doi: 10.1177/1099800411398479. Epub 2011 Mar 8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with General Anesthesia, run by Guangzhou General Hospital of Guangzhou Military Command 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weifeng Tu, PhD (+8613922116606, wftuyx02@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol Dose (time frame: through study completion, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429309, which also lists 10 linked publications.
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 12 Feb 2018; AzTrials last refreshed its copy on 26 Oct 2026.