Clinical trial NCT04183296: The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy
Keywords: Laparoscopic assisted gastrectomy
Robotic assisted gastrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in blood concentration of syndecan-1
timeFrame: after anesthesia induction <before surgery(base concentration)>
measure: Changes in blood concentration of syndecan-1
timeFrame: at the end of surgery
measure: Changes in blood concentration of syndecan-1
timeFrame: 1 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
citation: 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.