NCT03892538

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
Last Updated

March 27, 2019

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

March 13, 2019

Last Update Submit

March 26, 2019

Conditions

Keywords

StressBlood pressureHeart rateCorticotropinCortisol

Outcome Measures

Primary Outcomes (6)

  • systolic blood pressure

    mmHg

    Change from skin incision till 10 minutes after skin incision

  • diastolic blood pressure

    mmHg

    Change from skin incision till 10 minutes after skin incision

  • mean arterial pressure

    mmHg

    Change from skin incision till 10 minutes after skin incision

  • heart rate

    bpm

    Change from skin incision till 10 minutes after skin incision

  • corticotropin

    plasma concentration,pg/ml

    Change from skin incision till 10 minutes after skin incision

  • cortisol

    plasma concentration,nmol/L

    Change from skin incision till 10 minutes after skin incision

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (20)

  • 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.

    PMID: 17329347BACKGROUND
  • 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.

    PMID: 10927999BACKGROUND
  • 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.

    PMID: 26309669BACKGROUND
  • 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.

    PMID: 11119695BACKGROUND
  • 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.

    PMID: 19400714BACKGROUND
  • 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.

    PMID: 20727935BACKGROUND
  • 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.

    PMID: 20631016BACKGROUND
  • 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.

    PMID: 22577121BACKGROUND
  • 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.

    PMID: 17080694BACKGROUND
  • 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.

    PMID: 17505001BACKGROUND
  • 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.

    PMID: 28212354BACKGROUND
  • 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.

    PMID: 20928962BACKGROUND
  • 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.

    PMID: 1530752BACKGROUND
  • 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.

    PMID: 24743579BACKGROUND
  • 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.

    PMID: 2240678BACKGROUND
  • Freise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4.

    PMID: 22058144BACKGROUND
  • Sidiropoulou I, Tsaousi GG, Pourzitaki C, Logotheti H, Tsantilas D, Vasilakos DG. Impact of anesthetic technique on the stress response elicited by laparoscopic cholecystectomy: a randomized trial. J Anesth. 2016 Jun;30(3):522-5. doi: 10.1007/s00540-016-2148-7. Epub 2016 Feb 16.

    PMID: 26882921BACKGROUND
  • Ryu KH, Kim JA, Ko DC, Lee SH, Choi WJ. Desflurane reduces intraoperative remifentanil requirements more than sevoflurane: comparison using surgical pleth index-guided analgesia. Br J Anaesth. 2018 Nov;121(5):1115-1122. doi: 10.1016/j.bja.2018.05.064. Epub 2018 Jul 4.

    PMID: 30336856BACKGROUND
  • Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.

    PMID: 18997532BACKGROUND
  • Sabourdin N, Diarra C, Wolk R, Piat V, Louvet N, Constant I. Pupillary Pain Index Changes After a Standardized Bolus of Alfentanil Under Sevoflurane Anesthesia: First Evaluation of a New Pupillometric Index to Assess the Level of Analgesia During General Anesthesia. Anesth Analg. 2019 Mar;128(3):467-474. doi: 10.1213/ANE.0000000000003681.

    PMID: 30198934BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jing Cang, PHD

    Director

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 27, 2019

Study Start

October 1, 2018

Primary Completion

March 10, 2019

Study Completion

March 10, 2019

Last Updated

March 27, 2019

Record last verified: 2018-10

Locations