NCT02315482

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

November 24, 2014

Last Update Submit

June 23, 2015

Conditions

Autonomic Nervous System

Keywords

autonomic nervous systemheart rate variabilityprostatectomysteep trendelenburgpneumoperitoneumIntervention Affecting Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

  • changes of High Frequency and Low Frequency spectral heart rate power induced by pneumoperitoneum and steep trendelenburg

    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

    60 min

Secondary Outcomes (1)

  • changes of symbolic patterns induced by pneumoperitoneum and steep trendelenburg

    60 min

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

pneumoperitoneum insufflation and steep trendelenburgPROCEDURE

the sequence of pneumoperitoneum insufflation and steep trendelenburg positioning is randomized

Group AGroup B

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Luigi Sacco Hospital

Milan, 20157, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Related Publications (11)

  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

    PMID: 8598068BACKGROUND

  • Akselrod S, Gordon D, Ubel FA, Shannon DC, Berger AC, Cohen RJ. Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981 Jul 10;213(4504):220-2. doi: 10.1126/science.6166045.

    PMID: 6166045BACKGROUND

  • Charkoudian N, Martin EA, Dinenno FA, Eisenach JH, Dietz NM, Joyner MJ. Influence of increased central venous pressure on baroreflex control of sympathetic activity in humans. Am J Physiol Heart Circ Physiol. 2004 Oct;287(4):H1658-62. doi: 10.1152/ajpheart.00265.2004. Epub 2004 Jun 10.

    PMID: 15191897BACKGROUND

  • Deutschman CS, Harris AP, Fleisher LA. Changes in heart rate variability under propofol anesthesia: a possible explanation for propofol-induced bradycardia. Anesth Analg. 1994 Aug;79(2):373-7. doi: 10.1213/00000539-199408000-00031.

    PMID: 7639382BACKGROUND

  • Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.

    PMID: 18200624BACKGROUND

  • Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009 May;55(5):1037-63. doi: 10.1016/j.eururo.2009.01.036. Epub 2009 Jan 25.

    PMID: 19185977BACKGROUND

  • Gainsburg DM, Wax D, Reich DL, Carlucci JR, Samadi DB. Intraoperative management of robotic-assisted versus open radical prostatectomy. JSLS. 2010 Jan-Mar;14(1):1-5. doi: 10.4293/108680810X12674612014266.

    PMID: 20529522BACKGROUND

  • Harrison MH, Rittenhouse D, Greenleaf JE. Effect of posture on arterial baroreflex control of heart rate in humans. Eur J Appl Physiol Occup Physiol. 1986;55(4):367-73. doi: 10.1007/BF00422735.

    PMID: 3758036BACKGROUND

  • Hu JC, Gu X, Lipsitz SR, Barry MJ, D'Amico AV, Weinberg AC, Keating NL. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA. 2009 Oct 14;302(14):1557-64. doi: 10.1001/jama.2009.1451.

    PMID: 19826025BACKGROUND

  • Guzzetti S, Borroni E, Garbelli PE, Ceriani E, Della Bella P, Montano N, Cogliati C, Somers VK, Malliani A, Porta A. Symbolic dynamics of heart rate variability: a probe to investigate cardiac autonomic modulation. Circulation. 2005 Jul 26;112(4):465-70. doi: 10.1161/CIRCULATIONAHA.104.518449. Epub 2005 Jul 18.

    PMID: 16027252BACKGROUND

  • Montano N, Ruscone TG, Porta A, Lombardi F, Pagani M, Malliani A. Power spectrum analysis of heart rate variability to assess the changes in sympathovagal balance during graded orthostatic tilt. Circulation. 1994 Oct;90(4):1826-31. doi: 10.1161/01.cir.90.4.1826.

    PMID: 7923668BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Autonomic activity during laparoscopic prostatectomy

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 12, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

IT(2)