Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study.
Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jan 30, 2020
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect Summary
Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response. This effect is related to postoperative recovery, pain scores, opioid consumption, bowel function recovery, morbidity and possibly mortality. Therefore, low impact laparoscopy, meaning low pressure PNP facilitated by deep NMB, could be a valuable addition to Enhanced Recovery After Surgery (ERAS) Protocols.
The use of low pressure PNP may also reduce hypoxic injury and the release of DAMPs and thereb...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • - Age ≥ 18 years
- • Undergoing elective robot assisted radical prostatectomy (RARP)
- • Obtained informed consent
- Exclusion Criteria:
- • Laparoscopic radical prostatectomy without robot assistance
- • Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
- • Neo-adjuvant chemotherapy
- • Chronic use of analgesics or psychotropic drugs
- • Use of NSAID's shorter than 5 days before surgery
- • Severe liver- or renal disease
- • Neuromuscular disease
- • Hyperthyroidism or thyroid adenomas
- • Deficiency of vitamin K dependent clotting factors or coagulopathy
- • Planned diagnostics or treatment with radioactive iodine \< 1 week after surgery
- • Indication for rapid sequence induction
- • BMI \>35kg/m2
- • Known of suspected hypersensitivity to ICG, sodium iodide, iodine, rocuronium or sugammadex
- • Use of medication interfering with ICG absorption as listed in the summary of product characteristics (SPC); anticonvulsants, bisulphite compounds, haloperidol, heroin, meperidine, metamizol, methadone, morphium, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane, probencid
About Radboud University Medical Center
Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nijmegen, , Netherlands
Patients applied
Trial Officials
Michiel Warle, Dr.
Principal Investigator
Radboud University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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