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

N/ACompletedNCT02025075

Massachusetts General Hospital37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Regional Change in Air Content (Delta Z, %)

We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6). Percent change was calculated using electrical impedance measurements obtained at time T0 as reference.

Time frame: BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum

Ejection Fraction (%)

To assess cardiac performance, transthoracic echocardiography will be used. Ejection fraction was measured as fractional shortening (FS). FS is the fraction of any diastolic dimension that is lost in systole. FS = 100\*(LVEDD - LVESD) / LVEDD, LVEDD = LV end-diastolic dimension (mm); LVESD = LV end-systolic dimension (mm).

Cerebral Oximetry (%)

Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.

Secondary Outcomes

Postoperative Pain

The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as incisional pain using VAS (0 = no pain; 100 = worst possible pain).

Time frame: Postoperative Day 1