GastrostomyNCT04183296
The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy
A study testing propofol and sevoflurane in people with Gastrostomy, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastrostomy
- What is being tested?
- propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Nov 2019to 3 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 20 years old with ASA class I-III
- Scheduled laparoscopic or robotic assisted laparoscopic gastrectomy
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
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.
- Conditions
- Gastrostomy
- Being tested
- propofol, sevoflurane
- Keywords
- Laparoscopic assisted gastrectomy, Robotic assisted gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called 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.
sevofluraneDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood concentration of syndecan-1
Blood levels of syndecan-1 are assessed at 10 minutes after anesthesia induction.
Measured: 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.
Measured: at the end of surgery
Changes in blood concentration of syndecan-1
Blood levels of syndecan-1 are assessed 1 day after surgery.
Measured: 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start28 Nov 2019
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Trial
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183296
- Sponsor's protocol ID
- 4-2019-0924
- Status last verified
- Sep 2020
- First submitted
- 28 Nov 2019
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04183296
- Acronym / sponsor ID
- 4-2019-0924
- Conditions
- Gastrostomy
- Keywords
- Laparoscopic assisted gastrectomy, Robotic assisted gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| TIVA(Total Intravenous Anesthesia and Volatile Anesthesia ) | Experimental | Drug: propofolIn 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. |
| Inhalation | Active comparator | Drug: sevofluraneArm 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over 20 years old with ASA class I-III
- Scheduled laparoscopic or robotic assisted laparoscopic gastrectomy
Key exclusion criteria (4 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: TIVA groupAnesthesia 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 | TIVA(Total Intravenous Anesthesia and Volatile Anesthesia ) |
| sevofluraneAlso: volatile groupAnesthesia 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 | Inhalation |
Primary outcome
Changes in blood concentration of syndecan-1
Time frame: after anesthesia induction <before surgery(base concentration)>
Blood levels of syndecan-1 are assessed at 10 minutes after anesthesia induction.
Changes in blood concentration of syndecan-1
Time frame: at the end of surgery
Blood levels of syndecan-1 are assessed at the end of surgery.
Changes in blood concentration of syndecan-1
Time frame: 1 day after surgery
Blood levels of syndecan-1 are assessed 1 day after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Derived from this study: PubMed 33452350Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and sevoflurane in people with Gastrostomy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood concentration of syndecan-1 (time frame: after anesthesia induction <before surgery(base concentration)>). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.