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

NCT ID: NCT03201744

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-29
• Study Completion Date: 2020-09-30

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.

Conditions

Hernia, Ventral; Neuromuscular Blockade; Pneumoperitoneum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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 Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

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 Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Spaniolas

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantinos Spaniolas, MD

Role: PRINCIPAL_INVESTIGATOR

StonyBrook University Hospital

Locations

Shabana Humayon

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shabana Humayon, MPH

Role: CONTACT

shabana.humayon@stonybrookmedicine.edu

631-638-0292

Dawn Alomar, MBA

Role: CONTACT

dawn.alomar@stonybrookmedicine.edu

631-444-8209

Facility Contacts

Shabana Humayon

Role: primary

shabana.humayon@stonybrookmedicine.edu

631-532-7167

Other Identifiers

1034023-3

Identifier Type: -

Identifier Source: org_study_id