A randomized controlled trial comparing deep versus moderate neuromuscular block - in low pressure pneumoperitoneum - to optimize the surgical conditions during laparoscopic donor nephrectomy

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 donor nephrectomy, such as less
post-operative pain, better quality of life and shorter hospital stay1.
Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice.
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 complication rate2-4. We therefore believe that further
research should focus on the optimization of early postoperative recovery.
Postoperative recovery is largely determined by the consequences of
postoperative pain and its concomitant use of opioids. Measures to reduce
postoperative pain would also reduce the occurrence of postoperative
drowsiness, nausea and vomitus, and postoperative bowel dysfunction.
Pain after laparoscopic surgery can be divided into three components: a)
superficial wound pain, b) deep intra-abdominal pain and c) referred shoulder
pain5. A recent pilot study performed by our group (Radboudumc) showed that the
use of low pressure pneumoperitoneum (7 mmHg) was feasible and significantly
reduced deep intra-abdominal and referred pain scores during the first 72 hours
after surgery6. Previous studies by others show that low pressure
pneumoperitoneum during laparoscopic Nissen fundoplication and laparoscopic
cholecystectomy is associated with a reduction of the systemic inflammatory
response, less adverse impact on the peritoneal environment, post-operative
pain and analgesic consumption7-10. However, low pressure pneumoperitoneum can
decrease peri-operative conditions. A recent study performed by our group
(LUMC) showed that profound muscle relaxation improves surgical conditions
during laparoscopic surgery with standard pressure pneumoperitoneum11. To
facilitate the use of low pressure pneumoperitoneum, profound muscle relaxation
-in theory- improves surgical conditions and might become a prerequisite for
the use of low pressure pneumoperitoneum.

To investigate whether the use of deep neuromuscular block improves surgical
conditions in low pressure laparoscopic donor nephrectomy

multi-center, single-blind, randomized, controlled clinical trial

The patient will be randomized in one the following study groups:
• Low pressure pneumoperitoneum (6 mmHg) and deep neuromuscular blockade (goal:
TOF 0-1 twitches)
• Low pressure pneumoperitoneum (6 mmHg) and moderate neuromuscular blockade
(goal: PTC 0-5)

The patient will be asked to fill in some questionnaires:
• Quality of recovery-40: 3x 5 minutes = 15 minutes
• Components of pain assessment: 3x 2 minutes = 6 minutes
• Nausea score = 3x 1 minute = 3 minutes

Total estimated less than 30 minutes