Colorectal CancerNCT02266056
The Benefits of Deep Neuromuscular Block and Sugammadex in Laparoscopic Colorectal Surgery
A study testing Deep neuromuscular block using rocuronium and reversal with suggamadex and Moderate neuromuscular block using rocuronium and reversal with suggamadex in people with Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an increased mean arterial pressure and systemic vascular resistance due to sympathetic excitation in the cardiovascular system. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Deep neuromuscular block using rocuronium and reversal with suggamadex and Moderate neuromuscular block using rocuronium and reversal with suggamadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Sep 2015
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 19 to 80 scheduled to undergo laparoscopic colorectal or rectal surgery below the ASA class 3
Who cannot join
- Patients with neuromuscular disease/patients with a personal history or family history of malignant hyperthermia/patients with a serious heart, kidney (GFR < 60) or liver condition (ALT/AST > 100)/ patients who have had colorectal or rectal surgery/obese patients (BMI ≥35)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center
Seoul, Seoul, 120-752
About this study
Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an increased mean arterial pressure and systemic vascular resistance due to sympathetic excitation in the cardiovascular system. 10~15 mmHg intra-abdominal pressure is required in order to achieve a pneumoperitoneum, and increased abdominal pressure following a pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by increasing the left ventricular end systolic wall stress and the right and left ventricular filling pressure, while decreasing the stroke volume and cardiac index. The author compared the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for colorectal cancer as part of preliminary research. The results showed that deep muscle relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by an average of 8. Above all, even after lowering the intra-abdominal pressure with deep muscle relaxation, the surgeon was able to maintain a view almost identical to the one afforded by medium muscle relaxation. However, up until now, no reports have clearly indicated the change in pneumoperitoneum pressure, the patient's hemodynamic change, post-operative recovery, and surgical prognosis depending on the depth of muscle relaxation.Against this background, this study aims to identify the degree to which intra-abdominal pressure in laparoscopic colorectal surgery can be reduced by deep muscle relaxation, and the corresponding advantages this method presents in terms of physiological changes such as hemodynamic and respiratory system changes. In addition, the study intends to examine the difference between deep muscle relaxation and medium muscle relaxation in terms of surgical prognosis, including their effects on post-operative pain and on the patient's recovery of intestinal mobility.
- Conditions
- Colorectal Cancer
- Being tested
- Deep neuromuscular block using rocuronium and reversal with suggamadex, Moderate neuromuscular block using rocuronium and reversal with suggamadex
- Keywords
- deep neuromuscular block, sugammadex, laparoscopic colorectal surgery, hemodynamic change
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular block using rocuronium and reversal with suggamadexDrug
Deep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion
Moderate neuromuscular block using rocuronium and reversal with suggamadexDrug
Moderate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular relaxation | Experimental | Not described Receives: Drug: Deep neuromuscular block using rocuronium and reversal with suggamadex |
| Moderate neuromuscular relaxation | Active comparator | Not described Receives: Drug: Moderate neuromuscular block using rocuronium and reversal with suggamadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-abdominal pressure
The difference of intra-abdominal pressure during peumoperitoneum between deep neuromuscular block and moderate neuromuscular block to identify the degree to which deep muscle relaxation can reduce intra-abdominal pressure while maintaining the surgeon's view in a laparoscopic colorectal surgery or laparoscopic rectal surgery, as well as examine the simultaneous hemodynamic changes and changes in the respiratory system.
Measured: 5 minuits after pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 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
- NCT02266056
- Sponsor's protocol ID
- 4-2014-0559
- Status last verified
- Oct 2015
- First submitted
- 26 Aug 2014
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Deep Neuromuscular Block and Sugammadex in Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02266056
- Acronym / sponsor ID
- 4-2014-0559
- Conditions
- Colorectal Cancer
- Keywords
- deep neuromuscular block, sugammadex, laparoscopic colorectal surgery, hemodynamic change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Oct 2014 (estimated)
- 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.
Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an increased mean arterial pressure and systemic vascular resistance due to sympathetic excitation in the cardiovascular system. 10~15 mmHg intra-abdominal pressure is required in order to achieve a pneumoperitoneum, and increased abdominal pressure following a pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by increasing the left ventricular end systolic wall stress and the right and left ventricular filling pressure, while decreasing the stroke volume and cardiac index. The author compared the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for colorectal cancer as part of preliminary research. The results showed that deep muscle relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by an average of 8. Above all, even after lowering the intra-abdominal pressure with deep muscle relaxation, the surgeon was able to maintain a view almost identical to the one afforded by medium muscle relaxation. However, up until now, no reports have clearly indicated the change in pneumoperitoneum pressure, the patient's hemodynamic change, post-operative recovery, and surgical prognosis depending on the depth of muscle relaxation.Against this background, this study aims to identify the degree to which intra-abdominal pressure in laparoscopic colorectal surgery can be reduced by deep muscle relaxation, and the corresponding advantages this method presents in terms of physiological changes such as hemodynamic and respiratory system changes. In addition, the study intends to examine the difference between deep muscle relaxation and medium muscle relaxation in terms of surgical prognosis, including their effects on post-operative pain and on the patient's recovery of intestinal mobility.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular relaxation | Experimental | Drug: Deep neuromuscular block using rocuronium and reversal with suggamadex |
| Moderate neuromuscular relaxation | Active comparator | Drug: Moderate neuromuscular block using rocuronium and reversal with suggamadex |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19 to 80 scheduled to undergo laparoscopic colorectal or rectal surgery below the ASA class 3
Key exclusion criteria (1 listed)
- Patients with neuromuscular disease/patients with a personal history or family history of malignant hyperthermia/patients with a serious heart, kidney (GFR < 60) or liver condition (ALT/AST > 100)/ patients who have had colorectal or rectal surgery/obese patients (BMI ≥35)
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 using rocuronium and reversal with suggamadexDeep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion | Drug | Deep neuromuscular relaxation |
| Moderate neuromuscular block using rocuronium and reversal with suggamadexModerate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion | Drug | Moderate neuromuscular relaxation |
Primary outcome
intra-abdominal pressure
Time frame: 5 minuits after pneumoperitoneum
The difference of intra-abdominal pressure during peumoperitoneum between deep neuromuscular block and moderate neuromuscular block to identify the degree to which deep muscle relaxation can reduce intra-abdominal pressure while maintaining the surgeon's view in a laparoscopic colorectal surgery or laparoscopic rectal surgery, as well as examine the simultaneous hemodynamic changes and changes in the respiratory system.
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 19 Oct 2015.
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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 using rocuronium and reversal with suggamadex and Moderate neuromuscular block using rocuronium and reversal with suggamadex in people with Colorectal 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 1 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 19 Oct 2015. 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?
intra-abdominal pressure (time frame: 5 minuits after pneumoperitoneum). 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 19 Oct 2015.