N/A N=97 Randomized Triple-blind Prevention

Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study.

Quality of Life · Postoperative Complications · Acute Pain · Immune System Tolerance

Bottom Line

View on ClinicalTrials.gov: NCT04250883 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Feb 2025

Primary outcome: Primary: Quality of Recovery - 40 Items Questionnaire Score (QoR-40) — 162.7; 167.6 score on a scale of 200 — p=0.54

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Low intra-abdominal pressure (Other); Deep neuromuscular blockade (NMB) (Other); Standard intra-abdominal pressure (Other); Moderate neuromuscular blockade (NMB) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Radboud University Medical Center
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Quality of Recovery - 40 Items Questionnaire Score (QoR-40)	186.6; 186.8	—
PRIMARY Quality of Recovery - 40 Items Questionnaire Score (QoR-40)	186.6; 186.8	—
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
SECONDARY Chronic Pain With McGill Pain Questionnaire (MPQ)	3.2; 4.2	—
SECONDARY Perfusion Index of the Parietal Peritoneum	82.2; 78.5	—

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.

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

View full record on ClinicalTrials.gov →

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.