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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

October 25, 2010
April 8, 2012
September 2010
June 2012   (final data collection date for primary outcome measure)
degree of muscle trauma [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
serum CK and CRP levels are measured
Same as current
Complete list of historical versions of study NCT01228162 on ClinicalTrials.gov Archive Site
consumption of analgetics [ Time Frame: 3 days ] [ Designated as safety issue: No ]
consumption of piritramide is measured
Same as current
Not Provided
Not Provided
 
Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation
Not Provided

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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Muscle Relaxation
  • Muscle Trauma
  • Analgetic Consumption
  • Total Hip Replacement
Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation
effect of muscle relaxation on muscle trauma, control group without relaxation
  • Experimental: general anaesthesia
    patients receiving general anaesthesia and rocuronium bromide for muscle relaxation
    Intervention: Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation
  • Active Comparator: spinal anaesthesia
    patients receiving spinal anaesthesia without muscle relaxation
    Intervention: Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2012
June 2012   (final data collection date for primary outcome measure)

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

-
Both
55 Years to 80 Years
No
Contact: Jens Ebnet, MD jens_ebnet@yahoo.de
Germany
 
NCT01228162
Nr. 5615 Hanover Med. School
Yes
Dr. Jens Ebnet, Klinikum Hildesheim GmbH
Klinikum Hildesheim GmbH
Hanover Medical School
Not Provided
Klinikum Hildesheim GmbH
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP