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The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function After Robot-assisted Prostatectomy


Phase 4
19 Years
N/A
Open (Enrolling)
Both
Prostate Cancer

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Trial Information

The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function After Robot-assisted Prostatectomy


Diaphragmatic dysfunction after abdominal surgery can result in extended hospital stay and
increased medical costs, because it is related with atelectasis, lung collapse or pneumonia.
The mechanism of diaphragm dysfunction is thought to be from not only direct injury to
abdominal wall and viscera but inhibitory reflexes of phrenic activity. Thoracic or upper
abdominal surgery is suggested as a risk factor of postoperative diaphragm dysfunction, and
perioperative analgesic modality is also known to affect diaphragm movements. But there has
been no trial to investigate the effect of laparoscopic pelvic surgery such as prostatectomy
on diaphragm movement. Moreover, it is not clear if minimally invasive Robot-assisted
laparoscopic radical prostatectomy (RALRP) has any influence on respiratory and diaphragm
functions.


Inclusion Criteria:



- Patients of over 18 years of age undergoing elective Robot-assisted laparoscopic
radical prostatectomy

Exclusion Criteria:

- Patients with previous history of smoking, cardiopulmonary or neuromuscular disease
or obesity (body mass index > 30 kg.m-2)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change of diaphragm movement using sonography (diaphragm inspiratory amplitude, diaphragm inspiratory and expiratory velocity)on postoperative day 1 and 2 from baseline (day before surgery)

Outcome Description:

The measurements of diaphragmatic motion were attained at the posterior surface of the diaphragm. From the tracings on M-mode, the distance between echogenic lines (DIA) in cm and diaphragm inspiratory/expiratory velocity in cm.s-1 during quiet, deep, and sniff breathing were measured on the frozen images. Three consecutive sonographic examinations were performed, and the highest value of three measurements was recorded

Outcome Time Frame:

on the day before surgery until postoperative day 2

Safety Issue:

No

Principal Investigator

Young Jun Oh, M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Severance Hospital, Yonsi University Health System

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

4-2007-0344

NCT ID:

NCT01547416

Start Date:

November 2011

Completion Date:

May 2012

Related Keywords:

  • Prostate Cancer
  • Diaphragmatic dysfunction
  • General anesthesia
  • Epidural Anesthesia
  • Prostatic Neoplasms

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