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The Association Between Telomere Length and Propofol Dose in Anesthesia-induction

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ClinicalTrials.gov Identifier: NCT03429309
Recruitment Status : Unknown
Verified November 2017 by Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Propofol Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Association Between Telomere Length in Peripheral Blood Leukocyte and Propofol Dose in Anesthesia-induction
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : February 1, 2018
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
Anesthesia-induction with propofol Drug: Propofol
Anesthesia was induced by intravenous infusion of propofol via the syringe pump at a rate of 30 mg/kg/h.


Outcome Measures
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Primary Outcome Measures :
  1. Propofol Dose [ Time Frame: through study completion, up to 6 months ]
    Dosage of propofol in anesthesia-induction.

  2. Telomere Length [ Time Frame: through study completion, up to 6 months ]
    Telomere length of peripheral blood leukocyte


Secondary Outcome Measures :
  1. Time of anesthesia-induction. [ Time Frame: through study completion, up to 6 months ]
    Time counted from the beginning of anesthesia-induction to patient consciousness disappearance.

  2. HR [ Time Frame: through study completion, up to 6 months ]
    Heart Rate

  3. BP [ Time Frame: through study completion, up to 6 months ]
    Blood Pressure

  4. BIS [ Time Frame: through study completion, up to 6 months ]
    BIS index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were scheduled for elective surgical procedures

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429309


Contacts
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Contact: Weifeng Tu, PhD +8613922116606 wftuyx02@163.com

Locations
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China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Weifeng Tu, PhD    +8613922116606    wftuyx02@163.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
More Information
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Publications:

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Responsible Party: Weifeng Tu, Chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT03429309    
Other Study ID Numbers: Telomere length and propofol
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command:
telomere
propofol
anesthesia-induction
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics