N/A
Completed N=97
Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study.
Source: ClinicalTrials.gov NCT04250883 ↗Enrolled (actual)
97
Serious AEs
2.1%
Results posted
Feb 2025
Primary outcomePrimary: Quality of Recovery - 40 Items Questionnaire Score (QoR-40) — 162.7; 167.6 score on a scale of 200 — p=0.54
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. In clinical practice standard pressures of 12-16mmHg are applied instead of the lowest possible IAP, but accumulating evidence shows lower pressure pneumoperitoneum (PNP) (6-8mmHg) to be non-compromising for sufficient workspace, when combined with deep neuromuscular blockade (NMB) in a vast majority of patients. 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 thereby contributing to a better preservation of innate immune function which may help to reduce the risk of infectious complications.
The participants will be randomly assigned to one of the experimental groups with low impact laparoscopy or one of the control groups with standard laparoscopy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Recovery - 40 Items Questionnaire Score (QoR-40) |
186.6; 186.8 | — |
| SECONDARY Health Status With Short Form Survey (SF-36) |
81.1; 81.8; 61.5; 64.3; 73.7; 77.9 | 0.64 |
| SECONDARY Chronic Pain With McGill Pain Questionnaire (MPQ) |
3.2; 4.2 | — |
| SECONDARY Operating Conditions |
4.9; 4.9 | 0.9 |
| SECONDARY Pain Score With NRS |
4.1; 3.9; 2.3; 2.3; 2.3; 2.2 | 0.68 |
| SECONDARY Postoperative Nausea and Vomiting (PONV) |
1; 0; 45; 50; 8; 4 | 0.63 |
| SECONDARY Analgesia Use |
6.2; 5.9; 1.3; 0.9 | 0.89 |
| SECONDARY Hospital Stay |
1.3; 1.24 | 0.42 |
| SECONDARY Complications |
8; 10; 38; 40; 4; 1 | 0.92 |
| SECONDARY Perfusion Index of the Parietal Peritoneum |
82.2; 78.5 | — |
| SECONDARY Immune Response Represented by IL-10 |
6.43; 7.25; 11.72; 13.94; 7.24; 8.89 | 0.35 |
| SECONDARY Immune Response Represented by IL-6 |
6.60; 8.67; 20.07; 24.38; 8.26; 11.95 | 0.99 |
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 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
Data sourced from ClinicalTrials.gov (NCT04250883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.