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Effect of Pneumoperitoneum and Steep Trendelenburg on Autonomic Nervous System

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ClinicalTrials.gov Identifier: NCT02315482
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : June 25, 2015
Sponsor:
Collaborators:
Andrea Marchi
Ferdinando Raimondi
Alberto Porta
Stefano Guzzetti
Tommaso Fossali
Information provided by (Responsible Party):
Riccardo Colombo, ASST Fatebenefratelli Sacco

Brief Summary:
The purpose of this study is to assess the different effects of pneumoperitoneum and steep trendelenburg position on autonomic nervous system modulation during laparoscopic prostatectomy

Condition or disease Intervention/treatment Phase
Autonomic Nervous System Procedure: pneumoperitoneum insufflation and steep trendelenburg Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : December 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Group A
after induction of general anesthesia (i) a pneumoperitoneum is induced then (ii) patient is placed in steep trendelenburg position at 25 degrees head down
Procedure: pneumoperitoneum insufflation and steep trendelenburg
the sequence of pneumoperitoneum insufflation and steep trendelenburg positioning is randomized

Experimental: Group B
after induction of general anesthesia (i) the patient is placed in steep trendelenburg position at 25 degrees head down then (ii) a pneumoperitoneum is induced
Procedure: pneumoperitoneum insufflation and steep trendelenburg
the sequence of pneumoperitoneum insufflation and steep trendelenburg positioning is randomized




Primary Outcome Measures :
  1. changes of High Frequency and Low Frequency spectral heart rate power induced by pneumoperitoneum and steep trendelenburg [ Time Frame: 60 min ]
    changes of autonomic nervous system activity independently elicited by (i) pneumoperitoneum and (ii) steep trendelenburg position. The High Frequency and Low Frequency spectral power of beat-to-beat heart intervals will be assessed with autoregressive analysis and expressed in msec^2


Secondary Outcome Measures :
  1. changes of symbolic patterns induced by pneumoperitoneum and steep trendelenburg [ Time Frame: 60 min ]
    changes of autonomic nervous system activity independently elicited by (i) pneumoperitoneum and (ii) steep trendelenburg position. The autonomic nervous activity will be analyzed by means of symbolic analysis of beat-to-beat heart intervals and expressed as percentage of triplets



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males scheduled for elective laparoscopic prostatectomy
  • sinus rhythm at electrocardiogram
  • ectopic heart beats <5% of all heart beats
  • american society of anesthesiologists status 1-3

Exclusion Criteria:

  • autonomic dysfunction (documented or suspected)
  • adrenal or thyroid dysfunction
  • organ dysfunction secondary to diabetes (i.e. nephropathy, retinopathy, neuropathy)
  • history of stroke, traumatic spinal injury, heart surgery or major vascular surgery
  • intracranial hypertension (documented or suspected)
  • hydrocephalus
  • New York Heart Association cardiac functional status ≥ IIb
  • non sinusal heart rhythm
  • ectopic heart beats ≥5% of normal heart beats
  • therapy with beta-blockers or beta2-agonists

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315482


Locations
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Italy
Luigi Sacco Hospital
Milan, Italy, 20157
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Sponsors and Collaborators
ASST Fatebenefratelli Sacco
Andrea Marchi
Ferdinando Raimondi
Alberto Porta
Stefano Guzzetti
Tommaso Fossali

Publications:

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Responsible Party: Riccardo Colombo, Autonomic activity during laparoscopic prostatectomy, ASST Fatebenefratelli Sacco
ClinicalTrials.gov Identifier: NCT02315482     History of Changes
Other Study ID Numbers: Prostate2
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Riccardo Colombo, ASST Fatebenefratelli Sacco:
autonomic nervous system
heart rate variability
prostatectomy
steep trendelenburg
pneumoperitoneum
Intervention Affecting Autonomic Nervous System

Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases