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Stress, PsychologicalNCT03892538

Correlation Between Blood Pressure, Heart Rate and Plasma Corticotropin, Cortisol Under Surgical Skin Incision

An observational study of Stress, Psychological, run by JingCang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective observational study was conducted to analyze the correlation between systolic blood pressure, diastolic blood pressure, mean arterial pressure,heart rate and plasma corticotropin, cortisol during surgical skin incision. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stress, Psychological
How many people
134 participants
Where
1 siteChina
Study dates
1 Oct 2018to 10 Mar 2019
Phase
Observational
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

Study population: The enrolled patients were mainly male and the type of surgery was open upper abdominal surgery

Who may be able to join

  • the ASA score was from grade I to III,
  • aged 18-80 years

Who cannot join

  • adrenal gland related diseases
  • immune system related diseases
  • severe cardiovascular and cerebrovascular diseases,
  • severe liver and kidney dysfunction
  • refuse to participate in this study

Trial locations and contacts

1 site in 1 country.

China1 site
  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

A prospective observational study was conducted to analyze the correlation between systolic blood pressure, diastolic blood pressure, mean arterial pressure,heart rate and plasma corticotropin, cortisol during surgical skin incision.

Read the detailed description

The elements of general anesthesia include sedation, analgesia and muscle relaxation, while the essence of intraoperative pain in patients under general anesthesia is the body's unconscious response to tissue damage, namely the stress response.Stress response is a series of hormonal and metabolic changes produced by the body in response to nociceptive stimuli. It is part of the systemic response to injury and includes a wide range of endocrine, immunological and hemodynamic effects.Operation as well as the modern medicine common disease treatment, as a harmful stimulation, can cause the body strong stress reaction, reaction and duration and the size of the surgery is often proportional to the damage degree, its mechanism mainly include the activation of the sympathetic nervous system, adrenocorticotropic hormone (ACTH), growth hormone, vasopressin (AVP), cortisol and aldosterone and a series of hypothalamus pituitary adrenal axis hormone changes, insulin resistance and stress hyperglycemia, IL - 1, IL - 6, TNF alpha, such as the change of cytokines,And the increase in acute phase reactions such as acute response phase protein (CRP).As a protective response, stress response can mobilize the energy stored in the body when the body is injured, and help the body survive in harsh environment.But now a good perioperative management environment means that patients can be adequately nourished even after surgery.In this case, excessive stress response leads to preoperative anxiety of patients, the occurrence of adverse events in the intraoperative central blood vessels, and the occurrence of postoperative complications.In surgical patients, many systems, including the brain, are negatively affected by stress hormones.Perioperative acute stress can lead to post-traumatic stress disorder, depression, postoperative fatigue, chronic pain, and cognitive decline in elderly patients.Perioperative hyperglycemia and insulin resistance are closely related to postoperative infection and cardiovascular events, and may prolong hospital stay.Perioperative stress response will also damage the immune function of patients, which is mainly manifested as inhibition of natural killer cell function and inhibition of innate immune function response, which brings concerns about postoperative infection and tumor recurrence of patients.Anesthesia can inhibit the intraoperative stress of patients to a certain extent. Different anesthesia drugs and anesthesia methods can be selected for the same operation.Dexmedetomidine has dose-dependent sedative, analgesic, anti-anxiety and hypnotic effects. It can reduce serum s-100 protein, lipid peroxidation product malondialdehyde (MDA), raise the level of hyper oxide dismutase (SOD), and reduce TNF-, il-1, il-6 and other pro-inflammatory mediators.Fentanyl, rui fentanyl, sufentanil opioids can inhibit the hypothalamus pituitary adrenal axis, decrease the plasma levels of stress hormones, but this does not mean that the investigators can in the art of unlimited increase the drug, also want to consider the stability of hemodynamics, respiratory depression caused by delayed awakening, postoperative nausea and vomiting, postoperative itching and postoperative recovery of gastrointestinal, etc.;Epidural anesthesia with segmental sympathetic nerve blocking effect, in the chest surgery, general anesthesia compound epidural block than all by intravenous anesthesia, the patient's heart rate, blood pressure, mean arterial pressure, such as index significantly more smoothly, catecholamine levels in peripheral blood, the incidence of postoperative adverse events also significantly reduced.Real-time monitoring of the intraoperative stress level of patients is helpful for the anesthesiologist to determine the depth of anesthesia and guide the intraoperative anesthesia medication.There are many ways to monitor the level of intraoperative stress in patients.Surgical volume index (SPI) is used to monitor the pain-analgesic balance during general anesthesia through heartbeat interval and pulse wave amplitude measured by light.Skin pain conductance meter (SCA) assesses the size and pain of nociceptive stimulation through sweating and skin conductance.The pupil pain index (PPI) monitors intraoperative pain by measuring changes in pupil size caused by nociceptive stimulation.All of these indicators were used to monitor the intraoperative stress level through sympathetic or parasympathetic nerve activity. However, the intraoperative acute stress response was related to the state of high adrenocorticotropin and high cortisol. Currently, there is no index to evaluate the intraoperative pain of patients based on the change of intraoperative stress hormone level.However, the changes of stress hormones must be detected by laboratory tests. Therefore, whether the changes of stress hormones can be estimated by the blood pressure and heart rate that the investigators routinely monitor during the operation, so as to provide a research direction for us to establish the intraoperative pain monitoring method with stress hormones as the evaluation standard.In summary, this clinical study analyzed the relationship between the changes of systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate under surgical curettage stimulation and the changes of plasma adrenocorticotrophin and cortisol through prospective observational studies, and found out the indexes that could reflect the changes of stress hormones during the operation.

Keywords
Stress, Blood pressure, Heart rate, Corticotropin, Cortisol
Medical subject headings
Stress, Psychological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. systolic blood pressure

    mmHg

    Measured: Change from skin incision till 10 minutes after skin incision

  2. diastolic blood pressure

    mmHg

    Measured: Change from skin incision till 10 minutes after skin incision

  3. mean arterial pressure

    mmHg

    Measured: Change from skin incision till 10 minutes after skin incision

  4. heart rate

    bpm

    Measured: Change from skin incision till 10 minutes after skin incision

  5. corticotropin

    plasma concentration,pg/ml

    Measured: Change from skin incision till 10 minutes after skin incision

  6. cortisol

    plasma concentration,nmol/L

    Measured: Change from skin incision till 10 minutes after skin incision

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start1 Oct 2018
  3. Primary completion10 Mar 2019
  4. Study completion10 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03892538
Sponsor's protocol ID
B2018-288R
Status last verified
Oct 2018
First submitted
13 Mar 2019
Last updated
27 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data not yet collated

Publications

  • Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.

    PubMed 17329347
  • Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.

    PubMed 10927999
  • Pan YS, Hu YF, Tian FB, Xu K. Effects of epidural preemptive analgesia on stress reaction in retroperitoneal laparoscopic adrenalectomy surgery: a randomized controlled study. Int J Clin Exp Med. 2015 Jun 15;8(6):9862-8. eCollection 2015.

    PubMed 26309669
  • McEwen BS. The neurobiology of stress: from serendipity to clinical relevance. Brain Res. 2000 Dec 15;886(1-2):172-189. doi: 10.1016/s0006-8993(00)02950-4.

    PubMed 11119695
  • Rodrigues SM, LeDoux JE, Sapolsky RM. The influence of stress hormones on fear circuitry. Annu Rev Neurosci. 2009;32:289-313. doi: 10.1146/annurev.neuro.051508.135620.

    PubMed 19400714
  • Borsook D, George E, Kussman B, Becerra L. Anesthesia and perioperative stress: consequences on neural networks and postoperative behaviors. Prog Neurobiol. 2010 Dec;92(4):601-12. doi: 10.1016/j.pneurobio.2010.08.006. Epub 2010 Aug 19.

    PubMed 20727935
  • Sato H, Carvalho G, Sato T, Lattermann R, Matsukawa T, Schricker T. The association of preoperative glycemic control, intraoperative insulin sensitivity, and outcomes after cardiac surgery. J Clin Endocrinol Metab. 2010 Sep;95(9):4338-44. doi: 10.1210/jc.2010-0135. Epub 2010 Jul 14.

    PubMed 20631016
  • Ljungqvist O. Jonathan E. Rhoads lecture 2011: Insulin resistance and enhanced recovery after surgery. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):389-98. doi: 10.1177/0148607112445580. Epub 2012 May 10.

    PubMed 22577121
  • Nygren J. The metabolic effects of fasting and surgery. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):429-38. doi: 10.1016/j.bpa.2006.02.004.

    PubMed 17080694
  • Liu Z, Jiang M, Zhao J, Ju H. Circulating tumor cells in perioperative esophageal cancer patients: quantitative assay system and potential clinical utility. Clin Cancer Res. 2007 May 15;13(10):2992-7. doi: 10.1158/1078-0432.CCR-06-2072.

    PubMed 17505001
  • Li Y, Liu S. The Effect of Dexmedetomidine on Oxidative Stress Response Following Cerebral Ischemia-Reperfusion in Rats and the Expression of Intracellular Adhesion Molecule-1 (ICAM-1) and S100B. Med Sci Monit. 2017 Feb 17;23:867-873. doi: 10.12659/msm.899855.

    PubMed 28212354
  • Anand KJ, Sippell WG, Aynsley-Green A. Randomised trial of fentanyl anaesthesia in preterm babies undergoing surgery: effects on the stress response. Lancet. 1987 Jan 31;1(8527):243-8. doi: 10.1016/s0140-6736(87)90065-1.

    PubMed 20928962
  • Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.

    PubMed 1530752
  • Li C, Xu M, Wu Y, Li YS, Huang WQ, Liu KX. Limb remote ischemic preconditioning attenuates lung injury after pulmonary resection under propofol-remifentanil anesthesia: a randomized controlled study. Anesthesiology. 2014 Aug;121(2):249-59. doi: 10.1097/ALN.0000000000000266.

    PubMed 24743579
  • Hopf HB, Weissbach B, Peters J. High thoracic segmental epidural anesthesia diminishes sympathetic outflow to the legs, despite restriction of sensory blockade to the upper thorax. Anesthesiology. 1990 Nov;73(5):882-9. doi: 10.1097/00000542-199011000-00015.

    PubMed 2240678

Questions about this trial

What is this clinical trial studying?

An observational study of Stress, Psychological, run by JingCang 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 2 inclusion and 5 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 27 Mar 2019. 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?

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?

systolic blood pressure (time frame: Change from skin incision till 10 minutes after skin incision). The study lists 6 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 NCT03892538, which also lists 20 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 27 Mar 2019.

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