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CompletedNCT02602964LEOPARD-3Updated Apr 4, 2016

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

A Phase 4 interventional study of Deep neuromsucular block in Nephrostomy; Complications, Pneumoperitoneum and Observation of Neuromuscular Block, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-04.

Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Nephrostomy; Complications
  • Pneumoperitoneum
  • Observation of Neuromuscular Block

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In context

Pneumoperitoneum

149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.

This study's enrollment of 34 is below the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.

Browse Pneumoperitoneum studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • obtained informed consent
  • age over 18 years

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Deep neuromsucular block

    Deep neuromuscular block and low pressure pneumoperitoneum

    Other: Deep neuromsucular block

  • No intervention
    Standard neuromuscular block

    Standard neuromuscular block and low pressure pneumoperitoneum

Interventions

  • OtherDeep neuromsucular block

    Deep or standard neuromuscular block

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What researchers measure

Primary outcomes

  1. Mean surgical rating score

    Time frame: perioperative

Secondary outcomes

  1. Conversion to standard pressure pneumoperitoneum

    Time frame: perioperative

  2. Intra-operative complications

    Time frame: perioperative

  3. Length of pneumoperitoneum

    Time frame: perioperative

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Study locations

1 site
  • Radboud University Medical Center
    Nijmegen, 6500 HB, Netherlands
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References and documents

Publications

  • Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1. PubMed 34879862 ↗
  • Ozdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warle MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22. PubMed 28643056 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02602964
Lead sponsor
Radboud University Medical Center
Collaborators
Leiden University Medical Center
Responsible party
Sponsor
First posted
Nov 11, 2015
Start date
Apr 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Apr 4, 2016

Study contacts

Denise Özdemir-van Brunschot, MD PhD
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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