The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function

July 9, 2013 updated by: Yonsei University

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

The aim of this study was to investigate whether robot assisted laparoscopic radical prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and whether combined general/epidural anesthesia could provide better postoperative diaphragmatic function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Severence Hospital, Yonsei University Health System

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

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combined general/epidural anesthesia
epidural catheter was inserted in group GE at T8/9, T9/10, or T10/11 interspinous space with a 17-gauge Tuohy needle in lateral decubitus position and advanced 5 cm cephalad. Epidural analgesia was maintained using the patient-controlled analgesia technique.
Drug: epidural 250mL of 0.2% ropivacaine and 2 μg/mL of fentanyl, 5 mL/hr continuous infusion and 0.5 mL bolus dose

Before the induction of anesthesia, epidural catheter was inserted in group GE at T8/9, T9/10, or T10/11 interspinous space with a 17-gauge Tuohy needle in lateral decubitus position and advanced 5 cm cephalad. .

Epidural analgesia was maintained using the patient-controlled analgesia technique containing 250 mL of 0.2% ropivacaine and 2 μg/mL fentanyl with setting of 5 mL/hr for continuous infusion and 0.5 mL of bolus dose. Lockout time was set to 15 min.

General anesthesia was induced with 2 mg/kg of propofol and 50 mg of rocuronium. After tracheal intubation, anesthesia was maintained with sevoflurane. All the patients were ventilated with controlled mode of 8 mL/kg of ideal body weight and respiratory rate was adjusted to maintain end-tidal carbon dioxide between 35-40 mmHg.
Active Comparator: General anesthesia
Patients allocated to general anesthesia group did not receive epidural anesthesia.
Drug: no epidural drug administered

Patients allocated to general anesthesia group and DID NOT receive epidural anesthesia.

General anesthesia was induced with 2 mg/kg of propofol and 50 mg of rocuronium. After tracheal intubation, anesthesia was maintained with sevoflurane. All the patients were ventilated with controlled mode of 8 mL/kg of ideal body weight and respiratory rate was adjusted to maintain end-tidal carbon dioxide between 35-40 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: on the day before surgery until postoperative day 2
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
on the day before surgery until postoperative day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pulmonary function test on postoperative day 1 and 2 from baseline (day before surgery)
Time Frame: on the day before surgery until postoperative day 2
Spirometric measurements included vital capacity (VCIN), forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC, peak expiratory flow rate (PEF), maximal midexpiratory flow rate (MMEF), tidal volume (VT), and expiratory residual volume (ERV)
on the day before surgery until postoperative day 2

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Young Jun Oh, M.D. Ph.D., Severance Hospital, Yonsi University Health System

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

November 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2007-0344

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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