PneumoperitoneumNCT03576118
Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy
A study testing Deep neuromuscular block and Moderate neuromuscular block in people with Pneumoperitoneum, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- Deep neuromuscular block and Moderate neuromuscular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Nov 2018to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position
Who cannot join
- cerebrovascular disease
- uncontrolled hypertension, asthma, COPD
- neuromuscular disorder
- patients who have had abdominal surgery
- morbid obesity (body mass index > 35 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy
The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.
Read the detailed description
Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines.
The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).
- Conditions
- Pneumoperitoneum
- Being tested
- Deep neuromuscular block, Moderate neuromuscular block
- Keywords
- biotrauma, laparoscopic surgery, neuromuscular block, sugammadex
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular blockDrug
Also called Deep neuromuscular block with rocumeron
Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum
Moderate neuromuscular blockDrug
Also called Moderate neuromuscular block with rocumeron
Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular block | Experimental | Deep neuromuscular relaxation and low pressure pneumoperitoneum Receives: Drug: Deep neuromuscular block |
| Moderate neuromuscular block | Active comparator | Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Receives: Drug: Moderate neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Cytokine
change of IL-6 (pg/ml)
Measured: baseline, end of pneumoperitoneum, 24 hr 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 Jul 2018
- Study start5 Nov 2018
- Primary completion12 Jul 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumoperitoneumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, Principal investigator, Ajou University Hospital, Suwon, Gyeongki-do, Korea,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576118
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-115
- Status last verified
- May 2020
- First submitted
- 14 Jun 2018
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy
- ClinicalTrials.gov ID
- NCT03576118
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-115
- Conditions
- Pneumoperitoneum
- Keywords
- biotrauma, laparoscopic surgery, neuromuscular block, sugammadex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.
Detailed description
Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines.
The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular block | Experimental | Drug: Deep neuromuscular blockDeep neuromuscular relaxation and low pressure pneumoperitoneum |
| Moderate neuromuscular block | Active comparator | Drug: Moderate neuromuscular blockModerate neuromuscular relaxation and standard pressure pneumoperitoneum |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position
Key exclusion criteria (5 listed)
- cerebrovascular disease
- uncontrolled hypertension, asthma, COPD
- neuromuscular disorder
- patients who have had abdominal surgery
- morbid obesity (body mass index > 35 kg/m2)
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 blockAlso: Deep neuromuscular block with rocumeronDeep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum | Drug | Deep neuromuscular block |
| Moderate neuromuscular blockAlso: Moderate neuromuscular block with rocumeronModerate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum | Drug | Moderate neuromuscular block |
Primary outcome
Change of Cytokine
Time frame: baseline, end of pneumoperitoneum, 24 hr after surgery
change of IL-6 (pg/ml)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jong Yeop Kim principal investigator
Ajou University Hospital, Suwon, Gyeongki-do, Korea,
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 and Moderate neuromuscular block in people with Pneumoperitoneum, run by Ajou University School of Medicine 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 5 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 11 Jun 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?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Cytokine (time frame: baseline, end of pneumoperitoneum, 24 hr after surgery). 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 11 Jun 2020; AzTrials last refreshed its copy on 1 Nov 2026.