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A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum

A Randomized Controlled Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum - to Optimize the Surgical Conditions During Laparoscopic Donor Nephrectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02602964
Acronym
LEOPARD-3
Enrollment
34
Registered
2015-11-11
Start date
2015-04-30
Completion date
2016-02-29
Last updated
2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrostomy; Complications, Observation of Neuromuscular Block, Pneumoperitoneum

Brief summary

Live kidney transplantation is first choice for patients with end-stage kidney disease. Therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

Detailed description

However low pressure pneumoperitoneum can also decrease peri-operative conditions. In this trial the researchers will investigate whether peri-operative conditions during low pressure pneumoperitoneum can be optimized by the use of deep neuromuscular block.

Interventions

OTHERDeep neuromsucular block

Deep or standard neuromuscular block

Sponsors

Leiden University Medical Center
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* obtained informed consent * age over 18 years

Exclusion criteria

* chronic use of analgesics or psychotropic drugs * use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery * known or suspect allergy to rocuronium or sugammadex * significant liver or renal dysfunction * pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
Mean surgical rating scoreperioperative

Secondary

MeasureTime frame
Conversion to standard pressure pneumoperitoneumperioperative
Intra-operative complicationsperioperative
Length of pneumoperitoneumperioperative

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026