Stomach CancerNCT03937440
The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery
A study testing Deep neuromuscular block with 'rocunium®' and Moderate neuromuscular block with 'rocunium®' in people with Stomach Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Stress reactions caused by surgical stimuli can cause sympathetic nervous system activation and increased stress hormones, such as catecholamines, inflammatory cytokines, and pituitary hormones, and insulin resistance. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Stomach Cancer
- What is being tested?
- Deep neuromuscular block with 'rocunium®' and Moderate neuromuscular block with 'rocunium®'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2019to 15 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. ASA Ⅰ - Ⅱ patients between 20 and 65 years undergoing robot-assisted gastric cancer surgery
Who cannot join
- 1. Patients with neuromuscular disease
- 2. Hypertensive patients with β-blockers
- 3. Diabetic patients receiving insulin therapy
- 4. Patients with severe heart (EF <45%), kidney (GFR <60), liver dysfunction (ALT / AST> 100)
- 5. Patients with obesity (BMI ≥30)
- 6. Do not understand Korean language
- 7. For vulnerable subjects who are unable to obtain consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul
About this study
Stress reactions caused by surgical stimuli can cause sympathetic nervous system activation and increased stress hormones, such as catecholamines, inflammatory cytokines, and pituitary hormones, and insulin resistance. In addition, increased catecholamine levels may exacerbate postoperative outcomes, especially delayed wound recovery, increased cardiovascular and respiratory complications, and immunosuppression. In particular, it is important to reduce the stress response for cancer patients during surgery because they are already immunocompromised status and more vulnerable to perioperative stressful situation. However, there are insufficient results on the benefits of deep neuromuscular block in these patients, although some have reported a reduction of postoperative pain and fewer complications in the deep neuromuscular block compared with moderate neuromuscular block. Therefore, the investigators aim to investigate the difference in the stress response of patients who received conventional moderate neuromuscular block or deep neuromuscular block in robot-assisted gastric cancer surgery.
- Conditions
- Stomach Cancer
- Being tested
- Deep neuromuscular block with 'rocunium®', Moderate neuromuscular block with 'rocunium®'
- Keywords
- deep neuromuscular block, robot-assisted surgery, stress response, stomach cancer
- Medical subject headings
- Stomach Neoplasms, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular block with 'rocunium®'Drug
Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for post-tetanic count (PTC) in deep neuromuscular group.
Moderate neuromuscular block with 'rocunium®'Drug
Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for train-of-four (TOF) in moderate neuromuscular group.
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular block group | Experimental | Not described Receives: Drug: Deep neuromuscular block with 'rocunium®' |
| Moderate neuromuscular block group | Experimental | Not described Receives: Drug: Moderate neuromuscular block with 'rocunium®' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of stress responses between deep block and moderate block
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
Measured: at baseline (T1)
Difference of stress responses between deep block and moderate block
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
Measured: 90 min after CO2 inflation (T2)
Difference of stress responses between deep block and moderate block
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
Measured: at the end of pneumoperitoneum (about 3 hours after CO2 inflation) (T3)
Difference of stress responses between deep block and moderate block
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
Measured: 1 day after surgery (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start3 Jul 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 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
- NCT03937440
- Sponsor's protocol ID
- 4-2019-0205
- Status last verified
- Dec 2019
- First submitted
- 28 Apr 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery
- ClinicalTrials.gov ID
- NCT03937440
- Acronym / sponsor ID
- 4-2019-0205
- Conditions
- Stomach Cancer
- Keywords
- deep neuromuscular block, robot-assisted surgery, stress response, stomach cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 3 May 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.
Stress reactions caused by surgical stimuli can cause sympathetic nervous system activation and increased stress hormones, such as catecholamines, inflammatory cytokines, and pituitary hormones, and insulin resistance. In addition, increased catecholamine levels may exacerbate postoperative outcomes, especially delayed wound recovery, increased cardiovascular and respiratory complications, and immunosuppression. In particular, it is important to reduce the stress response for cancer patients during surgery because they are already immunocompromised status and more vulnerable to perioperative stressful situation. However, there are insufficient results on the benefits of deep neuromuscular block in these patients, although some have reported a reduction of postoperative pain and fewer complications in the deep neuromuscular block compared with moderate neuromuscular block. Therefore, the investigators aim to investigate the difference in the stress response of patients who received conventional moderate neuromuscular block or deep neuromuscular block in robot-assisted gastric cancer surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular block group | Experimental | Drug: Deep neuromuscular block with 'rocunium®' |
| Moderate neuromuscular block group | Experimental | Drug: Moderate neuromuscular block with 'rocunium®' |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. ASA Ⅰ - Ⅱ patients between 20 and 65 years undergoing robot-assisted gastric cancer surgery
Key exclusion criteria (7 listed)
- 1. Patients with neuromuscular disease
- 2. Hypertensive patients with β-blockers
- 3. Diabetic patients receiving insulin therapy
- 4. Patients with severe heart (EF <45%), kidney (GFR <60), liver dysfunction (ALT / AST> 100)
- 5. Patients with obesity (BMI ≥30)
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 |
|---|---|---|
| Deep neuromuscular block with 'rocunium®'Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for post-tetanic count (PTC) in deep neuromuscular group. | Drug | Deep neuromuscular block group |
| Moderate neuromuscular block with 'rocunium®'Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for train-of-four (TOF) in moderate neuromuscular group. | Drug | Moderate neuromuscular block group |
Primary outcome
Difference of stress responses between deep block and moderate block
Time frame: at baseline (T1)
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
Difference of stress responses between deep block and moderate block
Time frame: 90 min after CO2 inflation (T2)
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
Difference of stress responses between deep block and moderate block
Time frame: at the end of pneumoperitoneum (about 3 hours after CO2 inflation) (T3)
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
Difference of stress responses between deep block and moderate block
Time frame: 1 day after surgery (T4)
Comparison of perioperative stress responses with biomarkers including cortisol, interleukin-6, natural killer cell and HRV between deep neuromuscular block group and moderate neuromuscular group
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 18 Dec 2019.
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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 Deep neuromuscular block with 'rocunium®' and Moderate neuromuscular block with 'rocunium®' in people with Stomach Cancer, 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 1 inclusion and 7 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 18 Dec 2019. 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?
Difference of stress responses between deep block and moderate block (time frame: at baseline (T1)). The study lists 4 primary outcomes in all. 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 18 Dec 2019.