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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01547416
First received: February 27, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: epidural 250mL of 0.2% ropivacaine and 2 μg/mL of fentanyl, 5 mL/hr continuous infusion and 0.5 mL bolus dose
Drug: no epidural drug administered
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function After Robot-assisted Prostatectomy

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 50
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01547416

Locations
Korea, Republic of
Severence Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Young Jun Oh, M.D. Ph.D. Severance Hospital, Yonsi University Health System
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01547416     History of Changes
Other Study ID Numbers: 4-2007-0344
Study First Received: February 27, 2012
Last Updated: July 9, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Diaphragmatic dysfunction
General anesthesia
Epidural Anesthesia

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Anesthetics
Fentanyl
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local

ClinicalTrials.gov processed this record on August 28, 2014