Comparative Study Between Continuous Epidural Anesthesia And Continuous Spinal Anesthesia Using Wiley™ Spinal Catheter

This study has been completed.
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Yasser Mostafa Samhan, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier:
NCT01845389
First received: April 26, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

Geriatric patients have a significantly higher incidence of morbidity and morality during surgery compared with younger age group. Transurethral resection of the prostate (TURP) is the gold standard treatment for elderly patients with bladder outlet obstruction. Thus Regional techniques may be better tolerated in the elderly patients undergoing TURP having the advantages of minimizing blood loss and thromboembolic events. The Wiley Spinal™ (Epimed; Johnstown, NY) catheter is an innovative flexible cannula over needle designed for convenient intrathecal access that reduces PDPH. We hypothesized that using less anesthetics during continuous spinal anesthesia with the Wiley spinal catheter would offer more hemodynamic stability with less side effects when compared with continuous epidural anesthesia in patients undergoing TURP


Condition Intervention
Anesthesia; Adverse Effect, Spinal and Epidural
Device: Epidural (B. Braun)
Device: Spinal (Wiley Spinal Catheter)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Study Between Continuous Epidural Anesthesia Using Standard Epidural Catheter And Continuous Spinal Anesthesia Using Wiley™ Spinal Catheter In Geriatric Patients Undergoing TURP

Further study details as provided by Theodor Bilharz Research Institute:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: Participants will be followed for the duration of surgery, an expected average of 90 minutes ] [ Designated as safety issue: Yes ]
    Non- invasive blood pressure, heart rate and pulse oximetry will be recorded before administering anesthesia, immediately after placing the catheter, every 1min for the first 10 min, then every 5 min till end of the operation.


Secondary Outcome Measures:
  • detection of adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    failure of regional anesthesia (unilateral or patchy block), pruritus, dizziness, nausea, vomiting, itching, PDPH and symptoms suggestive of neurologic damage (back pain, numbness, weakness or pain in legs, and bladder or bowel dysfunction)


Enrollment: 30
Study Start Date: March 2012
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epidural
bupivacaine 0.5% 5 ml every 5 minutes for T10 sensory level
Device: Epidural (B. Braun)
Other Name: B. Braun
Active Comparator: Spinal
bupivacaine 0.5% 0.5 ml every 5 minutes for T10 sensory level
Device: Spinal (Wiley Spinal Catheter)
The Wiley Spinal® is an innovative Flexible Cannula over Needle designed for convenient intrathecal access. After dural puncture is achieved, an immediate dural seal is created. The flexible cannula is advanced off the needle ensuring cephalad delivery of medication.
Other Name: Wiley Spinal Catheter

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I, II or III
  • geriatric male patients
  • aged over 60 years
  • scheduled for elective TURP under regional anesthesia

Exclusion Criteria:

  • neurological diseases
  • mental disturbance
  • previous history of stroke
  • severe cardiopulmonary disorders
  • clinically significant coagulopathy
  • lumbar disc herniation
  • previous back surgery
  • infection at the injection site
  • body mass index greater than 35 kg/m2
  • hypersensitivity to amide local anesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845389

Locations
Egypt
Kasr El Aini University Hospital
Cairo, Egypt
Theodor Bilharz Research Institute
Giza, Egypt, 12511
Sponsors and Collaborators
Theodor Bilharz Research Institute
Cairo University
Investigators
Principal Investigator: Reeham S Ebeid, MD Theodor Bilharz Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: Yasser Mostafa Samhan, Prof Dr, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT01845389     History of Changes
Other Study ID Numbers: Anesth-2013
Study First Received: April 26, 2013
Last Updated: March 4, 2014
Health Authority: Egypt: Institutional Review Board
Egypt: Ministry of Higher Education

Keywords provided by Theodor Bilharz Research Institute:
Anesthesia
Regional
Epidural
Continuous spinal
Wiley Catheter
Geriatric
TURP

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014