Deep Neuromuscular Block During General Anaesthesia in Robotic Surgery

Study Overview
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Brief Summary
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The aim of this project is to show, whether the use of the deep neuromuscular block in certain laparoscopic robot-assisted surgery can positively influence main physiological functions compared to the use of standard neuromuscular block. Secondary outcome is to find out whether the targeted specific reversal of neuromuscular block by sugammadex improves and fastens the post-operative recovery of the patients.

Detailed Description
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Adequate muscle relaxation during general anaesthesia is crucial for easy, uncomplicated and safe laparoscopic and robot-assisted surgery. Perfect abdominal wall relaxation facilitates surgical working conditions, which makes surgery safer, faster and easier to perform. Besides this indirect advantage, there could be obvious benefit for patients. This is a result of decreased negative pathophysiological consequences of an increased intraabdominal pressure (capnoperitoneum) on important organ systems (cardiovascular, breathing system, kidneys etc.) Complete muscle relaxation during general anaesthesia can be achieved by using higher doses of rocuronium (non-depolarizing aminosteroid muscle relaxant) and special anaesthetic technique called deep neuromuscular block (DNMB). The primary focus of the project is to test the potential advantages of DNMB compared to standard relaxation technique. Safe and efficient use of NMBA is an important precondition in restoring a patient´s full muscle strength at the end of anaesthesia, to prevent effects of residual block. Modern practice of anaesthesia offers an option for complete and immediate rocuronium induced block reversal by using its specific antagonist - sugammadex. Combination of DNMB approach and sugammadex reversal also provide potential benefits for perioperative course and patient recovery after surgery. Secondary objective of the project is to verify this facts.

Official Title
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Deep Neuromuscular Block During General Anaesthesia in Laparoscopic (and Robotic Laparoscopic) Surgery and Its Potential Benefits for Certain Physiological Parameters in Perioperative Period

Conditions
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Observation of Neuromuscular Block, Complication of Ventilation Therapy, Postoperative Recovery

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine, Atropin Biotika


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Informed Consent Elective robotic radical prostatectomy American Society of Anesthesiologists (ASA) status 1-3 Exclusion Criteria: Inability to obtain Informed ConsentAge under 18 years American Society of Anesthesiologists (ASA) status over 3 Indication for rapid sequence induction, signs of difficult airway severe neuromuscular, liver or renal disease Known allergy to drugs used in the study Malignant hyperthermia (medical history)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Neuromuscular Block<br>Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Post-tetanic Count (PTC) = 1-2; PTC measurement every 4 min. Intervention: Neuromuscular blockade reversal at the end of anesthesia: sugammadex 2 mg/kg iv (when PTC is 18-20 and TOF-count 0) or sugammadex 4 mg/kg iv (when PTC under 18). Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1,5-2,5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv. Extubation when patient is conscious and attained recovery from neuromuscular blockade to a TOF-ratio of at least 0,9. | Drug: Sugammadex<br>* Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.<br>* Other names: Bridion;|
| Experimental: Moderate Neuromuscular Block<br>Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Train-of-Four (TOF) count = 1-2, TOF-count measurement every 1 min. Intervention: Neuromuscular blockade reversal at the end of anesthesia: neostigmine 0.03 mg/kg iv + atropine 0.5-1.0 mg iv Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1.5-2.5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv Extubation when patient is conscious and attained the recovery from neuromuscular blockade to a TOF-ratio of at least 0,9. | Drug: Neostigmine, Atropin Biotika<br>* Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.<br>* Other names: syntostigmine, atropine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical conditions SRS | Describes the quality of surgical conditions as reported by surgeon | Perioperative period | 
| Intraabdominal pressure IAP (mmHg) | Pressure in the abdominal cavity during capnoperitoneum | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating theatre time (min) | Time from induction to anesthesia to the release from operating theatre | during anesthesia | 
| Post-operative recovery | Physiological functions, level of discomfort, subjective evaluation by the patient | post-operative period (1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep neuromuscular block, laparoscopic surgery, robotic surgery, lung protective ventilation, respiratory functions, post-operative recovery