Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

Study Overview
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Brief Summary
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The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.

Official Title
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Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study

Conditions
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Laparoscopic Renal Surgery, Laparoscopy, Muscle Relaxation

Intervention / Treatment
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* Drug: Rocuronium
* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I or II patients scheduled to undergo laparoscopic renal surgery Exclusion Criteria: BMI ≥35 kg/m2 Known neuromuscular disease History of chronic obstructive pulmonary disease Asthma Pneumothorax Bronchopleural fistula Previous lung surgery Previous retroperitoneal surgery Hemodynamic instability History of cardiopulmonary disease Renal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dNMB group<br>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. | Drug: Rocuronium<br>* Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.<br>* Other names: Esmeron®;|
| Active Comparator: mNMB group<br>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count >2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. | Drug: Rocuronium<br>* Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.<br>* Other names: Esmeron®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoracopulmonary Compliance | Was measured with a patient spirometry monitor through a flow sensor. Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP). | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Oxygen Tension/Inspired Oxygen Fraction | Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP. | intraoperative | 
| Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP. | intraoperative | 
| Estimated Dead Space | Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP. | intraoperative | 
| Pulmonary Shunt | Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP. | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory mechanics, Respiratory function test, Hemodynamics