CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
Low intra-abdominal pressure +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04250883
NCT04250883N/ACompleted

Low Pressure Pneumoperitoneum and Deep Neuromuscular Blockade Versus Standard Laparoscopy During RARP to Improve the Quality of Recovery and Immune Homeostasis; Study Protocol for a Randomized Controlled Study

Radboud University Medical Center·interventional·Posted Jan 31, 2020·Updated Feb 5, 2025

In Brief

A clinical study evaluating Low intra-abdominal pressure, Deep neuromuscular blockade (NMB), and 2 other interventions for Quality of Life and 3 related conditions. Completed, enrolled 97 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 31, 2020
Enrollment StartDec 24, 2020
Primary CompletionDec 9, 2021
Study CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.4 years ago

Interventions

Low intra-abdominal pressureother

8 mmHg

Deep neuromuscular blockade (NMB)other

Deep NMB (PTC1-2)

Standard intra-abdominal pressureother

14 mmHg

Moderate neuromuscular blockade (NMB)other

Moderate NMB (TOF 1-2)