Status:
COMPLETED
Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Neuromuscular Blockade
Rocuronium
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular b...
Detailed Description
Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular b...
Eligibility Criteria
Inclusion
- Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: 'MAJOR', 'MAJOR Plus or 'COMPLEX MAJOR'
- ASA (merican society of anesthesiologists) class I-III
- \> 18 years of age
- Ability to give oral and written informed consent
Exclusion
- Low or intermediate complexity laparoscopic procedures (BUPA 'SIMPLE' or 'INTER')
- Known or suspected neuromuscular disorders impairing neuromuscular function
- Allergies to muscle relaxants, anesthetics or narcotics mentioned in paragraph 5.2
- A (family) history of malignant hyperthermia
- Women who are or may be pregnant or are currently breast feeding
- Chronic use of any type of opioid or psychotropic drug
- Use of NSAID's shorter than 5 days before surgery
- Indication for rapid sequence induction
- Contra-indication for sugammadex use (e.g. known sugammadex allergy or Glomerular Filtration Rate \<30 ml/min)
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
731 Patients enrolled
Trial Details
Trial ID
NCT04124757
Start Date
February 11 2020
End Date
June 1 2024
Last Update
June 11 2025
Active Locations (8)
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1
Université De Lorraine
Nancy, Meurthe-et-Moselle, France, 54000
2
Istituto Nazionale Dei Tumori
Milan, Italy, 20133
3
RadboudUMC
Nijmegen, Gelderland, Netherlands, 6525GA
4
LUMC
Leiden, South Holland, Netherlands, 2333ZA