Hernia, VentralNCT03201744
Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
A study testing Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg) in people with Hernia, Ventral and Neuromuscular Blockade, run by Stony Brook University at 1 site in United States.
Trial summary
The proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia, Ventral, Neuromuscular Blockade, Pneumoperitoneum
- What is being tested?
- Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to Feb 2022
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age 18-75 years old
- Umbilical, ventral, epigastric, spigelian or incisional hernia
- Plan for laparoscopic ventral hernia repair with mesh
- Estimated fascial defect between 2-10 cm in maximum diameter
Who cannot join
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
- Inability to provide informed consent
- Body mass index of 35 or over
- Multiple recurrent hernias (>1)
- Creatinine clearance < 30 ml/min (using the Cockcroft-Gault calculation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook Hospital
Stony Brook, New York, 11794-8191
About this study
The proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.
Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each procedure, and the ability to perform low-pressure laparoscopic VHR.
Read more
Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be considered successful when scores are maintained at 4 or 5 throughout the duration of the procedure. Outcome for this aim will be the mean score for surgical condition assessment for each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be used as a surrogate of good visualization).
Specific Aim 3. Assess patient recovery with low and high insufflation pressures during laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication requirement, PONV incidence and severity will be assessed in multiple time points following surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey. Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.
- Conditions
- Hernia, Ventral, Neuromuscular Blockade, Pneumoperitoneum
- Being tested
- Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg)
- Medical subject headings
- Hernia, Ventral, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg)Procedure or surgery
All procedures will start with low insufflation pressure (8 mmHg). Surgical field assessment (scale 1-5) will be performed every 5 minutes (Martini Br J Anaesth 2014). If conditions are poor (rating 1-2), intraperitoneal insufflation will be incrementally increased (10 mmHg, 12 mmHg, 15 mmHg) every 5 minutes as needed.Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice. In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Neuromuscular Block | Experimental | Train of four count of 1-2. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice. In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays. Receives: Procedure: Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg) |
| Deep Neuromuscular Block | Experimental | Post tetanic count of 1-2. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice. In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays. Receives: Procedure: Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean insufflation pressure during each procedure as a continuous variable
Measured: will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
Secondary outcomes (3)
Surgical condition assessment
Measured: every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
PONV severity (analogue score) and incidence (binary)
Measured: it will be assessed at 30 minutes, 1 hour, 12 hours and 24 hours after the completion of laparoscopic ventral hernia repair
Patient satisfaction (QoR-15).
Measured: it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start29 Aug 2017
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: Site no longer participating.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Amy Rosenbluth, Stony Brook University
- Investigators
- Amy Rosenbluth, MD, Principal investigator, StonyBrook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201744
- Sponsor's protocol ID
- 1034023-3
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2017
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT03201744
- Acronym / sponsor ID
- 1034023-3
- Conditions
- Hernia, Ventral, Neuromuscular Blockade, Pneumoperitoneum
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site no longer participating.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 28 Jun 2017 (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 proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.
Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each procedure, and the ability to perform low-pressure laparoscopic VHR.
Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be considered successful when scores are maintained at 4 or 5 throughout the duration of the procedure. Outcome for this aim will be the mean score for surgical condition assessment for each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be used as a surrogate of good visualization).
Specific Aim 3. Assess patient recovery with low and high insufflation pressures during laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication requirement, PONV incidence and severity will be assessed in multiple time points following surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey. Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Neuromuscular Block | Experimental | Procedure: Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg)Train of four count of 1-2. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice. In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays. |
| Deep Neuromuscular Block | Experimental | Procedure: Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg)Post tetanic count of 1-2. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice. In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age 18-75 years old
- Umbilical, ventral, epigastric, spigelian or incisional hernia
- Plan for laparoscopic ventral hernia repair with mesh
- Estimated fascial defect between 2-10 cm in maximum diameter
Key exclusion criteria (5 listed)
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
- Inability to provide informed consent
- Body mass index of 35 or over
- Multiple recurrent hernias (>1)
- Creatinine clearance < 30 ml/min (using the Cockcroft-Gault calculation)
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 |
|---|---|---|
| Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg)All procedures will start with low insufflation pressure (8 mmHg). Surgical field assessment (scale 1-5) will be performed every 5 minutes (Martini Br J Anaesth 2014). If conditions are poor (rating 1-2), intraperitoneal insufflation will be incrementally increased (10 mmHg, 12 mmHg, 15 mmHg) every 5 minutes as needed.Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice. In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays. | Procedure or surgery | Deep Neuromuscular Block, Moderate Neuromuscular Block |
Primary outcome
Mean insufflation pressure during each procedure as a continuous variable
Time frame: will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
3 secondary outcomes
Surgical condition assessment
Time frame: every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
PONV severity (analogue score) and incidence (binary)
Time frame: it will be assessed at 30 minutes, 1 hour, 12 hours and 24 hours after the completion of laparoscopic ventral hernia repair
Patient satisfaction (QoR-15).
Time frame: it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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.
Amy Rosenbluth, MD principal investigator
StonyBrook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg) in people with Hernia, Ventral and Neuromuscular Blockade, run by Stony Brook University at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 24 Apr 2026. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean insufflation pressure during each procedure as a continuous variable (time frame: will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)). 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 24 Apr 2026.