Complication of Ventilation Therapy, Observation of Neuromuscular Block, Postoperative Recovery
Conditions
Keywords
deep neuromuscular block, laparoscopic surgery, robotic surgery, lung protective ventilation, respiratory functions, post-operative recovery
Brief summary
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
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.
Interventions
DRUGSugammadex
Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.
DRUGNeostigmine, Atropin Biotika
Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
Sponsors
Palacky University
University Hospital Olomouc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical conditions SRS | Perioperative period | Describes the quality of surgical conditions as reported by surgeon |
| Intraabdominal pressure IAP (mmHg) | During surgery | Pressure in the abdominal cavity during capnoperitoneum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating theatre time (min) | during anesthesia | Time from induction to anesthesia to the release from operating theatre |
| Post-operative recovery | post-operative period (1 week) | Physiological functions, level of discomfort, subjective evaluation by the patient |
Countries
Czechia
Outcome results
None listed