A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum (LEOPARD-3)

Radboud University Medical Center

Status and phase: Completed; Phase 4

Conditions: Observation of Neuromuscular Block; Pneumoperitoneum; Nephrostomy; Complications

Treatments: Other: Deep neuromsucular block

Study type: Interventional

Funder types: Other

Identifiers

NCT02602964

NL50874.091.14

Details and patient eligibility

About

Live kidney transplantation is first choice for patients with end-stage kidney disease. Therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

Full description

However low pressure pneumoperitoneum can also decrease peri-operative conditions. In this trial the researchers will investigate whether peri-operative conditions during low pressure pneumoperitoneum can be optimized by the use of deep neuromuscular block.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• obtained informed consent
• age over 18 years

Exclusion criteria

• 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
• pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Deep neuromsucular block

Experimental group

Description:

Deep neuromuscular block and low pressure pneumoperitoneum

Treatment:

Other: Deep neuromsucular block

Standard neuromuscular block

No Intervention group

Description:

Standard neuromuscular block and low pressure pneumoperitoneum