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

NCT01547416 | Completed Phase 4

• 1 other identifier: 4-2007-0344
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Diaphragmatic dysfunction; General anesthesia; Epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (1)

• Change in pulmonary function test on postoperative day 1 and 2 from baseline (day before surgery)

  on the day before surgery until postoperative day 2

Study Arms (2)

combined general/epidural anesthesia

EXPERIMENTAL

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

General anesthesia

ACTIVE COMPARATOR

Patients allocated to general anesthesia group did not receive epidural anesthesia.

Drug: no epidural drug administered

Interventions

epidural 250mL of 0.2% ropivacaine and 2 μg/mL of fentanyl, 5 mL/hr continuous infusion and 0.5 mL bolus dose DRUG

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.

combined general/epidural anesthesia

no epidural drug administered DRUG

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.

General anesthesia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severence Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Injections, Epidural; Ropivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Young Jun Oh, M.D. Ph.D.

  Severance Hospital, Yonsi University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 7, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

KR (1)