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

NCT02146417 | Completed

• 1 other identifier: MISP#51414
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Disease

Keywords

Low pressure pneumoperitoneum; Deep neuromuscular block

Outcome Measures

Primary Outcomes (1)

• Quality-of-Recovery 40 scale

  day 1

Secondary Outcomes (4)

• 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

Other Outcomes (4)

• Operation time

  Peri-operative

• Length of pneumoperitoneum

  Peri-operative

• Estimated blood loss

  Peri-operative

Study Arms (2)

Normal pressure pneumoperitoneum & deep neuromuscular block

ACTIVE COMPARATOR

Normal pressure pneumoperitoneum

Procedure: Normal pressure pneumoperitoneum (12 mmHg); Procedure: Deep neuromuscular block

Low pressure pneumoperitoneum & deep neuromuscular block

EXPERIMENTAL

Low pressure pneumoperitoneum

Procedure: Low pressure pneumoperitoneum; Procedure: Deep neuromuscular block

Interventions

Low pressure pneumoperitoneum PROCEDURE

Low pressure pneumoperitoneum & deep neuromuscular block

Normal pressure pneumoperitoneum (12 mmHg) PROCEDURE

Normal pressure pneumoperitoneum & deep neuromuscular block

Deep neuromuscular block PROCEDURE

Low pressure pneumoperitoneum & deep neuromuscular block; Normal pressure pneumoperitoneum & deep neuromuscular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• obtained informed consent
• age over 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 34879862 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.

  PMID: 32107359 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.

  PMID: 28608013 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.

  PMID: 26265279 DERIVED

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michiel Warlé, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

NL (1)