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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02146417
Other study ID # MISP#51414
Secondary ID
Status Completed
Phase N/A
First received May 21, 2014
Last updated November 9, 2015
Start date August 2014
Est. completion date October 2015

Study information

Verified date November 2015
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

As both patients with end-stage kidney disease and society benefit tremendously from live kidney donation, the safety and well-being of kidney donors are highly important objectives in live kidney donation. Laparoscopic donor nephrectomy has several advantages over open nephrectomy, such as less post-operative pain, better quality of life and shorter hospital stay. Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice in most countries.

So far, modifications of the technique of laparoscopic donor nephrectomy, i.e. hand-assisted and/or retroperitoneoscopic approaches, did not show a significant benefit with regard to safety as reflected by the conversion to open and postoperative complications rate. We therefore believe that further research should focus on the optimization of early postoperative pain and its concomitant use of opioids. Since non-steroidal anti-inflammatory drugs are contra-indicated before and after nephrectomy, the management of postoperative pain largely depends on the administration of opioids. Measures to reduce postoperative pain would also reduce the occurrence of postoperative nausea and vomitus, and postoperative bowel dysfunction.

A recent pilot study performed by our group showed that the use of low pressure pneumoperitoneum was feasible and significantly reduced deep intra-abdominal and referred pain score during the first 72 hours after surgery. Previous studies performed by others show that low pressure pneumoperitoneum is associated with reduction of systemic inflammatory response, post-operative pain and analgesic consumption. Martini et al have shown that deep neuromuscular block improves surgical conditions during laparoscopic surgery with standard intra-abdominal pressure. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block improves surgical conditions and might become a prerequisite for the use of low pressure pneumoperitoneum.

Our hypothesis is that the combination of low pressure pneumoperitoneum and deep neuromuscular block improves quality of recovery in the early post-operative phase.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- obtained informed consent

- age over 18 years

Exclusion Criteria:

- insufficient control of the Dutch language to read the patient information and to fill out the questionnaires

- 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

- neuromuscular disease

- pregnant of breastfeeding

- indication for rapid sequence induction

- liver dysfunction is defined as alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > twice the upper limit (extremely rare in live kidney donors) ** renal dysfunction is defined as serum creatinine twice the normal level and/or glomerular filtration rate < 60 ml/min (extremely rare in live kidney donors)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Low pressure pneumoperitoneum

Normal pressure pneumoperitoneum (12 mmHg)

Deep neuromuscular block


Locations

Country Name City State
Netherlands Radboudumc Nijmegen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Operation time Peri-operative No
Other Length of pneumoperitoneum Peri-operative No
Other Estimated blood loss Peri-operative Yes
Other Intra-operative complications Peri-operative Yes
Primary Quality-of-Recovery 40 scale day 1 No
Secondary Cumulative use of opioids Day -1;0;1;2;3 and Mon3 No
Secondary Cumulative use of other analgetics Day -1;0;1;2;3 No
Secondary Post-operative complications Day 0;1;2;3 and Month 3 Yes
Secondary Time to reach discharge criteria Day 0;1;2;3 No
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