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

Primary Purpose

Hernia, Ventral, Neuromuscular Blockade, Pneumoperitoneum

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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)
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Ventral

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Shabana HumayonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Moderate Neuromuscular Block

Deep Neuromuscular Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean insufflation pressure during each procedure as a continuous variable

Secondary Outcome Measures

Surgical condition assessment
PONV severity (analogue score) and incidence (binary)
Patient satisfaction (QoR-15).

Full Information

First Posted
June 22, 2017
Last Updated
January 14, 2019
Sponsor
Stony Brook University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03201744
Brief Title
Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
Official Title
Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral, Neuromuscular Blockade, Pneumoperitoneum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate Neuromuscular Block
Arm Type
Experimental
Arm Description
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.
Arm Title
Deep Neuromuscular Block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
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)
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Surgical condition assessment
Time Frame
every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
Title
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
Title
Patient satisfaction (QoR-15).
Time Frame
it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shabana Humayon, MPH
Phone
631-638-0292
Email
shabana.humayon@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn Alomar, MBA
Phone
631-444-8209
Email
dawn.alomar@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Spaniolas, MD
Organizational Affiliation
StonyBrook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shabana Humayon
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8191
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shabana Humayon
Phone
631-532-7167
Email
shabana.humayon@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Konstantinos Spaniolas

12. IPD Sharing Statement

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

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