Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/17/2019 |
Start Date: | August 29, 2017 |
End Date: | September 2020 |
Contact: | Shabana Humayon, MPH |
Email: | shabana.humayon@stonybrookmedicine.edu |
Phone: | 631-638-0292 |
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
1
site
Stony Brook, New York 11794
Principal Investigator: Konstantinos Spaniolas
Phone: 631-532-7167
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