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CompletedNCT04183296Updated Sep 22, 2020

The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy

An interventional study of propofol and sevoflurane in Gastrostomy, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-09-22.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study summary

The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 before and after laparoscopic or robotic assisted gastrectomy.

Read the detailed description

A commercial TIVA(Total Intravenous Anesthesia and Volatile Anesthesia ) pump was used for target-controlled infusion (TCI) of remifentanil and propofol. In the volatile group, anesthesia was induced with an intravenous bolus of propofol 1.5-2 mg/kg and TCI of remifentanil (effect-site concentration [Ce] of 4.0 ng/ml). In the TIVA group, anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). In the volatile group, anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration [MAC]) and TCI of remifentanil, while in the TIVA group, anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI(Patient State Index) of 25-50. Endotracheal intubation was performed after administration of intravenous rocuronium 1.2 mg/kg and neuromuscular blockade depth was maintained to a target of train-of-four of 0-2 with infusion of rocuronium during pneumoperitoneum.

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Conditions studied

  • Gastrostomy

Keywords

  • Laparoscopic assisted gastrectomy
  • Robotic assisted gastrectomy
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult patients over 20 years old with ASA class I-III
  2. Scheduled laparoscopic or robotic assisted laparoscopic gastrectomy

Exclusion criteria

Exclusion Criteria:

  1. emergency surgery
  2. patients unable to make their own decisions, illiterate, foreigners
  3. Allergy / hypersensitivity to sevoflurane or propofol 4, Current or past history or thrombosis / thromboembolism
  1. patients who are taking oral contraceptives 6. Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) 7. Patients receiving anticoagulants 8. pregnant and lactating women 9. Patients with history of psychiatric disease or neurological disease
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    TIVA(Total Intravenous Anesthesia and Volatile Anesthesia )

    In the TIVA group, anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). Anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI of 25-50.

    Drug: propofol

  • Active comparator
    Inhalation

    Arm Description: In the volatile group, anesthesia was induced with an intravenous bolus of propofol 1.5-2 mg/kg and TCI of remifentanil (effect-site concentration \[Ce\] of 4.0 ng/ml). Anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration) and TCI of remifentanil

    Drug: sevoflurane

Interventions

  • Drugpropofol

    Anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). Anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI of 25-50.

    Also known as: TIVA group

  • Drugsevoflurane

    Anesthesia was induced with an intravenous bolus of propofol 1.5-2 mg/kg and TCI of remifentanil (effect-site concentration \[Ce\] of 4.0 ng/ml). Anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration) and TCI of remifentanil

    Also known as: volatile group

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What researchers measure

Primary outcomes

  1. Changes in blood concentration of syndecan-1

    Blood levels of syndecan-1 are assessed at 10 minutes after anesthesia induction.

    Time frame: after anesthesia induction <before surgery(base concentration)>

  2. Changes in blood concentration of syndecan-1

    Blood levels of syndecan-1 are assessed at the end of surgery.

    Time frame: at the end of surgery

  3. Changes in blood concentration of syndecan-1

    Blood levels of syndecan-1 are assessed 1 day after surgery.

    Time frame: 1 day after surgery

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Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
    Seoul, 03722, Korea, Republic of
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References and documents

Publications

  • Kim NY, Kim KJ, Lee KY, Shin HJ, Cho J, Nam DJ, Kim SY. Effect of volatile and total intravenous anesthesia on syndecan-1 shedding after minimally invasive gastrectomy: a randomized trial. Sci Rep. 2021 Jan 15;11(1):1511. doi: 10.1038/s41598-021-81012-1. PubMed 33452350 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04183296
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Dec 3, 2019
Start date
Nov 28, 2019
Primary completion
Aug 3, 2020
Completion
Aug 3, 2020
Last update
Sep 22, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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