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

NCT04183296 | Completed

• 1 other identifier: 4-2019-0924
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrostomy

Keywords

Laparoscopic assisted gastrectomy; Robotic assisted gastrectomy

Outcome Measures

Primary Outcomes (3)

• Changes in blood concentration of syndecan-1

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

  after anesthesia induction <before surgery(base concentration)>

• Changes in blood concentration of syndecan-1

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

  at the end of surgery

• Changes in blood concentration of syndecan-1

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

  1 day after surgery

Study Arms (2)

TIVA(Total Intravenous Anesthesia and Volatile Anesthesia )

EXPERIMENTAL

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

Inhalation

ACTIVE COMPARATOR

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

propofol DRUG

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

TIVA(Total Intravenous Anesthesia and Volatile Anesthesia )

sevoflurane DRUG

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

Inhalation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• emergency surgery
• patients unable to make their own decisions, illiterate, foreigners
• Allergy / hypersensitivity to sevoflurane or propofol 4, Current or past history or thrombosis / thromboembolism
• \. 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33452350 DERIVED

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: triple (Participant, Care Provider, investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized Trial

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: November 28, 2019
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

KR (1)