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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal pressure pneumoperitoneum & deep neuromuscular block | Active Comparator | Normal pressure pneumoperitoneum |
|
| Low pressure pneumoperitoneum & deep neuromuscular block | Experimental | Low pressure pneumoperitoneum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low pressure pneumoperitoneum | Procedure |
| ||
| Normal pressure pneumoperitoneum (12 mmHg) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality-of-Recovery 40 scale | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative use of opioids | Day -1;0;1;2;3 and Mon3 | |
| Cumulative use of other analgetics | Day -1;0;1;2;3 | |
| Post-operative complications |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Peri-operative | |
| Length of pneumoperitoneum | Peri-operative | |
| Estimated blood loss |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Michiel Warlé, MD PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6500HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34879862 | Derived | 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. | |
| 32107359 |
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| Procedure |
|
| Deep neuromuscular block | Procedure |
|
| Day 0;1;2;3 and Month 3 |
| Time to reach discharge criteria | Day 0;1;2;3 |
| Peri-operative |
| Intra-operative complications | Peri-operative |
| Derived |
| Albers KI, van Helden EV, Dahan A, Martini CH, Bruintjes MHD, Scheffer GJ, Steegers MAH, Keijzer C, Warle MC. Early postoperative pain after laparoscopic donor nephrectomy predicts 30-day postoperative infectious complications: a pooled analysis of randomized controlled trials. Pain. 2020 Jul;161(7):1565-1570. doi: 10.1097/j.pain.0000000000001842. |
| 28608013 | Derived | Ozdemir-van Brunschot DMD, Scheffer GJ, van der Jagt M, Langenhuijsen H, Dahan A, Mulder JEEA, Willems S, Hilbrands LB, Donders R, van Laarhoven CJHM, d'Ancona FA, Warle MC. Quality of Recovery After Low-Pressure Laparoscopic Donor Nephrectomy Facilitated by Deep Neuromuscular Blockade: A Randomized Controlled Study. World J Surg. 2017 Nov;41(11):2950-2958. doi: 10.1007/s00268-017-4080-x. |
| 26265279 | Derived | Ozdemir-van Brunschot DM, Scheffer GJ, Dahan A, Mulder JE, Willems SA, Hilbrands LB, d'Ancona FC, Donders RA, van Laarhoven KJ, Warle MC. Comparison of the effectiveness of low pressure pneumoperitoneum with profound muscle relaxation during laparoscopic donor nephrectomy to optimize the quality of recovery during the early post-operative phase: study protocol for a randomized controlled clinical trial. Trials. 2015 Aug 12;16:345. doi: 10.1186/s13063-015-0887-7. |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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