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NCT02602964 Clinical Trial

A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum

Pneumoperitoneum Clinical Trial

— LEOPARD-3  

Official title:
A Randomized Controlled Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum - to Optimize the Surgical Conditions During Laparoscopic Donor Nephrectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02602964
Other study ID # NL50874.091.14
Secondary ID
Status Completed
Phase Phase 4
First received May 13, 2015
Last updated April 1, 2016
Start date April 2015
Est. completion date February 2016

Study information
Verified date April 2016
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Dutch Health Care Inspectorate
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Deep neuromsucular block
Deep or standard neuromuscular block

Locations
Country Name City State
Netherlands Radboud University Medical Center Nijmegen

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean surgical rating score perioperative Yes
Secondary Conversion to standard pressure pneumoperitoneum perioperative No
Secondary Intra-operative complications perioperative Yes
Secondary Length of pneumoperitoneum perioperative No
See also
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Completed NCT02853591 - Comparison of Pneumoinsufflation Modes and Pressure Settings in Gynecology N/A
Completed NCT03576118 - Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy N/A
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Withdrawn NCT03933254 - Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
Recruiting NCT03069586 - Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain N/A
Recruiting NCT01867814 - Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum N/A
Terminated NCT01854307 - The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements N/A
Completed NCT05992636 - Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy
Completed NCT03957837 - Optical Nerve Sheath Changes During Head Down Laparoscopy
Recruiting NCT06319053 - The Turbine-based Insufflator Safety and Feasibility Study N/A
Completed NCT04125173 - Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy N/A
Not yet recruiting NCT02690688 - Intra-abdominal Pressure and Dynamic Preload Variables N/A
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Completed NCT03928171 - The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery N/A