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

Gastrostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183296
• Other study ID #: 4-2019-0924
• Status: Completed
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: August 3, 2020

Study information

• Verified date: September 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients over 20 years old with ASA class I-III

2. Scheduled laparoscopic or robotic assisted laparoscopic gastrectomy

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

5. 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

Related Conditions & MeSH terms

• Gastrostomy

Intervention

Drug:
• propofol
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.
• sevoflurane
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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)>
Primary	Changes in blood concentration of syndecan-1	Blood levels of syndecan-1 are assessed at the end of surgery.	at the end of surgery
Primary	Changes in blood concentration of syndecan-1	Blood levels of syndecan-1 are assessed 1 day after surgery.	1 day after surgery