ow impact laparoscopy (low pressure pneumoperitoneum and deep neuromuscular blockade) versus standard laparoscopy during robot assisted radical prostatectomy to improve the quality of recovery and immune homeostasis; a randomized controlled study.
- Conditions
- postoperatief herstel en effect op immuunsysteem na robotgeassisteerd laparoscopische ingrepen.Postoperative recovery and immune homeostasis
- Registration Number
- NL-OMON49113
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
- Age * 18 years
- Undergoing elective robot assisted radical prostatectomy (RARP)
- Obtained informed consent
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method