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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal pressure pneumoperitoneum & deep neuromuscular block

Normal pressure pneumoperitoneum

Group Type ACTIVE_COMPARATOR

Normal pressure pneumoperitoneum (12 mmHg)

Intervention Type PROCEDURE

Deep neuromuscular block

Intervention Type PROCEDURE

Low pressure pneumoperitoneum & deep neuromuscular block

Low pressure pneumoperitoneum

Group Type EXPERIMENTAL

Low pressure pneumoperitoneum

Intervention Type PROCEDURE

Deep neuromuscular block

Intervention Type PROCEDURE

Interventions

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Low pressure pneumoperitoneum

Intervention Type PROCEDURE

Normal pressure pneumoperitoneum (12 mmHg)

Intervention Type PROCEDURE

Deep neuromuscular block

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No