Nephrostomy; ComplicationsPhase 4LEOPARD-3NCT02602964
A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum
A Phase 4 study testing Deep neuromsucular block in people with Nephrostomy; Complications and Pneumoperitoneum, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrostomy; Complications, Pneumoperitoneum, Observation of Neuromuscular Block
- What is being tested?
- Deep neuromsucular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obtained informed consent
- age over 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum - to Optimize the Surgical Conditions During Laparoscopic Donor Nephrectomy
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.
- Being tested
- Deep neuromsucular block
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromsucular blockOther
Deep or standard neuromuscular block
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromsucular block | Experimental | Deep neuromuscular block and low pressure pneumoperitoneum Receives: Other: Deep neuromsucular block |
| Standard neuromuscular block | No intervention | Standard neuromuscular block and low pressure pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean surgical rating score
Measured: perioperative
Secondary outcomes (3)
Conversion to standard pressure pneumoperitoneum
Measured: perioperative
Intra-operative complications
Measured: perioperative
Length of pneumoperitoneum
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nephrostomy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Denise Özdemir-van Brunschot, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602964
- Sponsor's protocol ID
- NL50874.091.14
- Acronym
- LEOPARD-3
- Status last verified
- Apr 2016
- First submitted
- 13 May 2015
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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 34879862Ozdemir-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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum - to Optimize the Surgical Conditions During Laparoscopic Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT02602964
- Acronym / sponsor ID
- LEOPARD-3 / NL50874.091.14
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromsucular block | Experimental | Other: Deep neuromsucular blockDeep neuromuscular block and low pressure pneumoperitoneum |
| Standard neuromuscular block | No intervention | –Standard neuromuscular block and low pressure pneumoperitoneum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- obtained informed consent
- age over 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep neuromsucular blockDeep or standard neuromuscular block | Other | Deep neuromsucular block |
Primary outcome
Mean surgical rating score
Time frame: perioperative
3 secondary outcomes
Conversion to standard pressure pneumoperitoneum
Time frame: perioperative
Intra-operative complications
Time frame: perioperative
Length of pneumoperitoneum
Time frame: perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Derived from this study: PubMed 34879862Reijnders-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.
- Derived from this study: PubMed 28643056Ozdemir-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Özdemir-van Brunschot, MD PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deep neuromsucular block in people with Nephrostomy; Complications and Pneumoperitoneum, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean surgical rating score (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602964, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.