Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.

Mass General Brigham

Status: Completed

Conditions: Postoperative Complications; Surgical Complications From General Anesthesia; Laparoscopy; Intraoperative Complications; Ventilator-Induced Lung Injury

Treatments: Drug: Rocuronium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02025075

Merck-50706

Details and patient eligibility

About

The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences intraoperative hemodynamic and cerebral oxygenation.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h
• Physical status ASA I - III

Exclusion criteria

• Pregnancy
• Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
• Previous lung surgery
• History of severe chronic obstructive pulmonary disease
• Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
• Mechanical ventilation within the last 30 days
• Neuromuscular disease
• Consented for another interventional study or refusal to participate in the present study
• Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 2 patient groups

Deep Neuromuscular Block (NMB)

Experimental group

Description:

Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).

Treatment:

Drug: Rocuronium

Moderate Neuromuscular block (NMB)

Active Comparator group

Description:

Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).

Treatment:

Drug: Rocuronium