Melatonin in Patients Under Carotid Endarterectomy
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the effects of melatonin in the regulation of
      the vascular injury in patients under carotid endarterectomy through population-based,
      randomized, double-blind, placebo-controlled trial.
    

Detailed description: 
      Trial Title: The protective effect of melatonin in patients under carotid endarterectomy
      Protocol: Investigators recruited eligible Han Chinese participants (aged 40-80) who were
      diagnosed with carotid stenosis and had indications for carotid endarterectomy (CEA).
      Participants were excluded if participants had undergone surgical contraindication, or
      cardiovascular disease, or cerebral infarction within 3 months, or psychiatric disorders, or
      cancer, or pregnant, or lactating, or taking antipsychotic drugs during perioperative period.
      Participants were randomly divided into groups of CEA with oral melatonin, CEA with oral
      placebo, and CEA with blank control. Participants in groups of CEA with oral melatonin and
      CEA with oral placebo took melatonin orally 6mg/day or placebo from 3 days before operation
      to 3 days after operation. Blood samples (about 3 milliliter) were taken at baseline, 6h
      after the operation and 24h after the operation. Through a series hospital clinical
      laboratory and related ELISA kits to detect endothelial cell injury and ischemia reperfusion
      in serum markers. Superoxide dismutase (SOD), malonaldehyde (MDA), S100B protein, endothelial
      nitric oxide synthase (eNOS), nuclear erythroid 2-related factor 2 (Nrf - 2), Interleukin 6
      (IL-6), nuclear transcription factor κB p65 (NF-κB p65) were included for analysis to verify
      whether melatonin have protective effect in patients under carotid endarterectomy. This trial
      is approved by the Ethical Committee of Peking Union Medical College Hospital (No ZS 1057).
      All participants completed a questionnaire and signed an informed consent document.
      Otherwise, participants will get appropriate economic compensation. To achieve treatment
      concealment, melatonin and placebo in appearance and package were identically. Trial
      associates monitored compliance with the masking procedure throughout the trial. All
      participants and study investigators were unaware of treatment allocation throughout the
      study. The randomization codes remained sealed until after data collection and cleaning, and
      completion of a masked analysis. The study team monitored and classified protocol deviations.
      Investigators summarized baseline clinical and demographic characteristics with descriptive
      statistics and then determined by the Univariate Analysis of Variance. All the data analyses
      were done using statistical software SPSS 20.0.

      Expected results: Compared with patients under CEA with placebo or blank, patients took
      melatonin have a lower vascular injury and ischemia reperfusion injury.

      Consent document: The potential risk, research as a treatment drug of melatonin may delay the
      metabolism of antipsychotic antipsychotic drug, so when investigators recruit psychiatric
      disorders or taking antipsychotic drugs orally during the 2 weeks of the trial should
      exclusion. As a Health care medicine. Melatonin is not suitable for children, so
      investigators selected recruiting participants under the age of 40 to 80.

      The measure to minimize the risk, fully inform the participants and their families the
      trial's advantages, disadvantages and desired effect. All participants totally agree with the
      subjects. In this process, at least three or more effective way to get contact with the
      medical staff or doctor and ensure that those unexpected accident should deserve effective
      tackle. Participants guarantee to comply with the criterion before start of the trial. Our
      research involves the application of melatonin is through the china food and drug
      administration (CFDA) approved to ensure its safety (include its chemical composition,
      structure, content parameters, main raw material and appropriate crowd). All staff is
      qualified medical professionals to guarantee the safety of all participants.

      The potential risks or discomfort, or inconvenience, or benefits for participants: So far,
      effective of melatonin in human include regulating sleep, anti-tumor, immune regulation,
      regulating of inflammation and immune and regulating blood lipid metabolism is confirmed.
      Adverse reactions is slow the delay of antipsychotic drug metabolism (so nearly one month ago
      and during period of the trial participants should not taking antipsychotic drugs) during the
      trial. The basic principle during the trial is ensure safety of participants.

      The relevant content consultation: Everyone have the right to consultation the research
      content through telephone: +86 01069152500 (principal investigator) and +86
      01069155817(Ethics committee).

      The rights of withdrew from the trial: Participate in the trial is completely voluntary. If
      for any reason, participants not willing to participate in, or do not wish to continue to
      participate in this trial, will not affect the rights and interests of participants. In
      addition, participants have the right to withdraw this trial at any time. If participants do
      not according to the doctor instructions, or for the sake of your health and benefits, the
      doctor or the researchers may also require participants to quit the trial.

      The compensation of research: If the participants have any unexpected accident relation with
      the trial, the compensation and responsibility will be provided by Peking union medical
      college hospital.

      Privacy protection: The privacy of every participant will be protected. The results of the
      trial in academic publications will not leak any information to identify your personal
      identity. Peking union medical college hospital will save everybody's data and guarantee not
      leak without authorization.

      Investigators declare no competing interests.
    

Intervention name(s): Melatonin; placebo; blank
Intervention type(s): Drug; Drug; Other
Intervention description(s): Patients under CEA taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.; Patients under CEA taking placebo orally from 3 days before operation to 3 days after operation.; Patients under CEA without taking melatonin or placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: carotid stenosis; melatonin; vascular injury; ischemia reperfusion