Comparison of Low Versus Normal Pressure Pneumoperitoneum - With Profound Low Versus Normal Pressure Pneumoperitoneum -With Profound Muscle Relaxation- During Laparoscopic Donor Nephrectomy

Study Overview
=================
Brief 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.

Official Title
-----------------
A Phase IV, Blinded, Randomized Controlled Trial to Compare 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

Conditions
-----------------
Renal Disease

Intervention / Treatment
-----------------
* Procedure: Low pressure pneumoperitoneum
* Procedure: Normal pressure pneumoperitoneum (12 mmHg)
* Procedure: Deep neuromuscular block


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal pressure pneumoperitoneum & deep neuromuscular block<br>Normal pressure pneumoperitoneum | Procedure: Normal pressure pneumoperitoneum (12 mmHg)<br> <br> Procedure: Deep neuromuscular block<br> <br> |
| Experimental: Low pressure pneumoperitoneum & deep neuromuscular block<br>Low pressure pneumoperitoneum | Procedure: Low pressure pneumoperitoneum<br> <br> Procedure: Deep neuromuscular block<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-of-Recovery 40 scale |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Day 0;1;2;3 and Month 3 | 
| Time to reach discharge criteria |  | Day 0;1;2;3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low pressure pneumoperitoneum, Deep neuromuscular block