Endoplasmic Reticulum StressNCT03561831
Effect of Anaesthesia on ER Stress in Cancer Patients
A study testing Propofol and Sevoflurane in people with Endoplasmic Reticulum Stress, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Investigate the change in endoplasmic reticulum stress after cancer surgery according to different anaesthetics including propofol and sevoflurane. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Endoplasmic Reticulum Stress
- What is being tested?
- Propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jun 2018to 29 May 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cancer
Who cannot join
- age under 19 years old
- allergy history to propofol or sevoflurane
- history of previous cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effects of Anaesthetic Agents on Endoplasmic Reticulum Stress During Cancer Surgery
Investigate the change in endoplasmic reticulum stress after cancer surgery according to different anaesthetics including propofol and sevoflurane.
Read the detailed description
We hypothesize propofol and sevoflurane based anesthesia would show different pattern of endoplasmic reticulum stress after cancer surgery in patients with cancer
- Conditions
- Endoplasmic Reticulum Stress
- Being tested
- Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
propofol based anesthesia
SevofluraneDrug
sevoflurane based anesthesia
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Active comparator | patients who anesthesized by propofol Receives: Drug: Propofol |
| sevoflurane group | Active comparator | patients who anesthesized by sevoflurane Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endoplasmic reticulum stress
Change in endoplasmic reticulum stress
Measured: baseline, postoperative 1 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start5 Jun 2018
- Primary completion29 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoplasmic Reticulum StressStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hyop Kim, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, Professor, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561831
- Sponsor's protocol ID
- KUH1160108
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2018
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effects of Anaesthetic Agents on Endoplasmic Reticulum Stress During Cancer Surgery
- ClinicalTrials.gov ID
- NCT03561831
- Acronym / sponsor ID
- KUH1160108
- Conditions
- Endoplasmic Reticulum Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 19 Jun 2018 (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.
Investigate the change in endoplasmic reticulum stress after cancer surgery according to different anaesthetics including propofol and sevoflurane.
Detailed description
We hypothesize propofol and sevoflurane based anesthesia would show different pattern of endoplasmic reticulum stress after cancer surgery in patients with cancer
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Active comparator | Drug: Propofolpatients who anesthesized by propofol |
| sevoflurane group | Active comparator | Drug: Sevofluranepatients who anesthesized by sevoflurane |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cancer
Key exclusion criteria (3 listed)
- age under 19 years old
- allergy history to propofol or sevoflurane
- history of previous cancer
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 |
|---|---|---|
| Propofolpropofol based anesthesia | Drug | propofol group |
| Sevofluranesevoflurane based anesthesia | Drug | sevoflurane group |
Primary outcome
Change in endoplasmic reticulum stress
Time frame: baseline, postoperative 1 hours and 24 hours
Change in endoplasmic reticulum stress
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 15 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Endoplasmic Reticulum Stress
RecruitingObservational study
Wolfram Syndrome and WFS1-related Disorders International Registry and Clinical Study
Wolfram Syndrome, Diabetes Mellitus
RecruitingPhase 1/2
Targeting Endoplasmic Reticulum Stress in Human Hypertension
Hypertension
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.
Seong-Hyop Kim, Professor principal investigator
Konkuk University Medical Center
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 Endoplasmic Reticulum Stress, run by Konkuk University Medical Center 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 1 inclusion and 3 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 15 Oct 2021. 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?
Change in endoplasmic reticulum stress (time frame: baseline, postoperative 1 hours and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2021.