Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade

Status Recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03201744
Study type	Interventional
Source	Stony Brook University
Contact	Shabana Humayon, MPH
Phone	631-638-0292
Email	shabana.humayon@stonybrookmedicine.edu
Status	Recruiting
Phase	N/A
Start date	August 29, 2017
Completion date	September 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05558969` - The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex	N/A
Completed	`NCT03168308` - Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients	Phase 4
Not yet recruiting	`NCT03978780` - Erector Spinae Block vs. Placebo Block Study	N/A
Completed	`NCT02892045` - Mindray Neuromuscular Transmission Transducer
Completed	`NCT02912039` - Electromyographic Assessment of the TetraGraph in Normal Volunteers
Completed	`NCT03427385` - Minimum Local Anesthetic Dose for Adductor Canal Block	N/A
Completed	`NCT01450813` - The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy	N/A
Completed	`NCT00535496` - Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)	Phase 3
Recruiting	`NCT05794503` - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex	Early Phase 1
Not yet recruiting	`NCT05993390` - Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients	N/A
Recruiting	`NCT04609410` - Bleeding in Laparoscopic Liver Surgery	N/A
Terminated	`NCT03649672` - The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor	N/A
Completed	`NCT05474638` - Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery	N/A
Completed	`NCT05687253` - Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery	Phase 2
Completed	`NCT05120999` - Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
Completed	`NCT03608436` - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery	Phase 4
Completed	`NCT03572413` - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis.	Phase 4
Recruiting	`NCT02930629` - Residual Block in Postoperative Anaesthetic Care Unit	N/A
Completed	`NCT02932254` - Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex	Phase 4
Completed	`NCT01828385` - Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms