Autonomic Nervous System Modulation During Laparoscopic Prostatectomy

November 3, 2014 updated by: Riccardo Colombo, ASST Fatebenefratelli Sacco
The purpose of this study is to measure the variations of autonomic nervous system (ANS) modulation directed to the heart and vessels induced by pneumoperitoneum and steep trendelenburg position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The association of pneumoperitoneum and steep trendelenburg position, commonly used during laparoscopic radical prostatectomy, leads to significant changes in hemodynamics. Many studies found modifications of cardiac output, stroke work index, arterial pressure, central vein pressure and wedge pressure. Moreover, there are reports of severe bradycardia and cardiac arrest following pneumoperitoneum in association with steep trendelenburg. A vagal hypertone (induced by the combination of these two factors) or sympathetic hypractivity (elicited by pneumoperitoneum) had been alternatively postulated to cause these hemodynamic changes. To date there are not sufficient physiologic evidences of modification of ANS activity during steep trendelenburg position in association with pneumoperitoneum.

ANS modulation is studied non invasively by means of heart rate variability and baroreflex sensitivity. Beat-to-beat intervals are computed detecting the QRS complex on the ECG and locating the R-apex using parabolic interpolation. The maximum arterial pressure within each R-to-R interval is taken as systolic arterial pressure (SAP). Sequences of 300 values are randomly selected inside each experimental condition. The power spectrum is estimated according to a univariate parametric approach fitting the series to an autoregressive model. Autoregressive spectral density is factorized into components each of them characterized by a central frequency. A spectral component is labeled as LF if its central frequency is between 0.04 and 0.15 Hz, while it is classified as HF if its central frequency is between 0.15 and 0.4 Hz. The HF power of R-to-R series is utilized as a marker of vagal modulation directed to the heart , while the LF power of SAP series is utilized as a marker of sympathetic modulation directed to vessels. The ratio of the LF power to the HF power assessed from R-to-R series is taken as an indicator simpatho-vagal balance directed to the heart. Baroreflex control in the low frequencies is computed as the square root of the ratio of LF(RR) to LF(SAP). Similarly baroreflex control in the high frequencies is defined as the square root of the ratio of HF(RR) to HF(SAP).

The optic nerve sheet's diameter is assessed echographically after induction of general anesthesia and at the end of the surgery.

Management of general anesthesia is standardized:

  • induction with propofol 1.5-2 mg/kg, Remifentanil Target Controlled Infusion (TCI) Ce 4 ng/ml , neuromuscolar blockade with cisatracurium 0.2 mg/kg.
  • Maintenance: Sevoflurane 0.6-1.5 MAC (State Entropy target: 40-60); Remifentanil TCI (range Ce 3-15 ng/ml) (Surgical Pleth Index target: 20-50).
  • mechanical ventilation at respiratory rate ≥14 breats/min, with tidal volume adjusted to maintain end-tidal carbon dioxide at 32-38 mmHg, and Pplateu <32 cmH2O.

Sample size:

to detect a difference in LF/HF ratio of 0.8 with a SD of 1.7, a power of 0.80 and type I error of 0.05, 37 patients are needed.

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20157
        • Azienda Ospedaliera "Luigi Sacco" - Polo Universitario - University of Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Human males undergoing elective laparoscopic prostatectomy

Description

Inclusion Criteria:

  • males scheduled for elective laparoscopic prostatectomy
  • sinus rhythm at ECG
  • 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
  • cardiac functional status ≥NYHA IIb
  • non sinusal heart rhythm
  • ectopic heart beats ≥5% of normal heart beats
  • therapy with beta-blockers or beta2-agonists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
brachytherapy
males undergoing elective laparoscopic radical prostatectomy steep trendelenburg position with pneumoperitoneum
Other: steep trendelenburg position with pneumoperitoneum
ANS activity and baroreflex modulation is assessed at (i) baseline; (ii) after induction of general anesthesia; (iii) after steep trendelenburg position (head down at 25 degrees); (iv) after induction of pneumoperitoneum and (v) after removal of trendelenburg and pneumoperitoneum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the changes of ANS modulation directed to the heart and to the vessels, and the changes of baroreflex control induced by steep trendelenburg position and pneumoperitoneum
Time Frame: Day of surgery
Day of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
To measure the correlation between ANS changes and hemodynamics
Time Frame: day of surgery
day of surgery

Other Outcome Measures

Outcome Measure
Time Frame
to measure changes of the optic nerve sheet's diameter during steep trendelenburg and pneumoperitoneum
Time Frame: day of surgery
day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Fatebenefratelli Sacco

Investigators

  • Study Chair: Ferdinando Raimondi, Director, Azienda Ospedaliera "L.Sacco"
  • Principal Investigator: Riccardo Colombo, Consultant, Azienda Ospedaliera "L.Sacco"
  • Study Director: Stefano Guzzetti, Director, Azienda Ospedaliera "L.Sacco"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 22, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE#371/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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