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Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair

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ClinicalTrials.gov Identifier: NCT03201744
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Konstantinos Spaniolas, Stony Brook University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Hernia, Ventral Neuromuscular Blockade Pneumoperitoneum 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Moderate Neuromuscular Block
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.
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)
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.

Experimental: Deep Neuromuscular Block
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.
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)
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.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Surgical condition assessment [ Time Frame: every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair) ]
  2. 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 ]
  3. Patient satisfaction (QoR-15). [ Time Frame: it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201744


Contacts
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Contact: Shabana Humayon, MPH 631-638-0292 shabana.humayon@stonybrookmedicine.edu
Contact: Dawn Alomar, MBA 631-444-8209 dawn.alomar@stonybrookmedicine.edu

Locations
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United States, New York
Shabana Humayon Recruiting
Stony Brook, New York, United States, 11794-8191
Contact: Shabana Humayon    631-532-7167    shabana.humayon@stonybrookmedicine.edu   
Principal Investigator: Konstantinos Spaniolas         
Sponsors and Collaborators
Stony Brook University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Konstantinos Spaniolas, MD StonyBrook University Hospital

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Responsible Party: Konstantinos Spaniolas, Associate Professor of Surgery, Stony Brook University
ClinicalTrials.gov Identifier: NCT03201744     History of Changes
Other Study ID Numbers: 1034023-3
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pneumoperitoneum
Pathological Conditions, Anatomical
Hernia, Abdominal
Peritoneal Diseases
Digestive System Diseases