Text Size

Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation

This study is currently recruiting participants.
Verified April 2012 by Klinikum Hildesheim GmbH
Sponsor:
Collaborator:
Hanover Medical School
Information provided by (Responsible Party):
Dr. Jens Ebnet, Klinikum Hildesheim GmbH
ClinicalTrials.gov Identifier:
NCT01228162
First received: October 25, 2010
Last updated: April 8, 2012
Last verified: April 2012
History of Changes
  Purpose

The researchers want to investigate the effects of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic consumption in patients with total hip prosthesis replacement (general vs. spinal anaesthesia).


Condition Intervention Phase
Muscle Relaxation
Muscle Trauma
Analgetic Consumption
Total Hip Replacement
 Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum Hildesheim GmbH:

Primary Outcome Measures:
  • degree of muscle trauma [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    serum CK and CRP levels are measured


Secondary Outcome Measures:
  • consumption of analgetics [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    consumption of piritramide is measured


Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: general anaesthesia
patients receiving general anaesthesia and rocuronium bromide for muscle relaxation
 Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation
effect of muscle relaxation on muscle trauma, control group without relaxation
Active Comparator: spinal anaesthesia
patients receiving spinal anaesthesia without muscle relaxation
 Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation
effect of muscle relaxation on muscle trauma, control group without relaxation

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patient agreement
  2. indication for total hip replacement
  3. age 55 - 80 years
  4. weight 65 - 95 kg
  5. first intervention
  6. ASA classification I - III
  7. general and spinal anaesthesia possible in this patient

Exclusion Criteria:

a) neuromuscular diseases b) surgery with muscle trauma (within the last 3 months) c) permanent immobility d) intramuscular injections (within the last 4 weeks) e) medication with opioids f) medication with co-analgetics g) contraindications for general or spinal anaesthesia h) dementia, cognitive dysfunction or sleep apnea

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228162

Contacts
Contact: Jens Ebnet, MD jens_ebnet@yahoo.de

Locations
Germany
Klinikum Hildesheim GmbH Recruiting
Hildesheim, Germany
Contact: Jens Ebnet, MD         jens_ebnet@yahoo.de    
Principal Investigator: Jens Ebnet, MD            
Sponsors and Collaborators
Klinikum Hildesheim GmbH
Hanover Medical School
  More Information

No publications provided

Responsible Party: Dr. Jens Ebnet, MD, Klinikum Hildesheim GmbH
ClinicalTrials.gov Identifier: NCT01228162     History of Changes
Other Study ID Numbers: Nr. 5615 Hanover Med. School
Study First Received: October 25, 2010
Last Updated: April 8, 2012
Health Authority: Hanover Medical School Germany ':'
law of Germany ':'

Additional relevant MeSH terms:
Muscle Hypotonia
Wounds and Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Rocuronium
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013