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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

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ClinicalTrials.gov Identifier: NCT01228162
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : June 25, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2010
Primary Completion Date : June 2013
Study Completion Date : June 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. degree of muscle trauma [ Time Frame: 24 hours ]
    serum CK and CRP levels are measured


Secondary Outcome Measures :
  1. consumption of analgetics [ Time Frame: 3 days ]
    consumption of piritramide is measured


Eligibility Criteria

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228162


Locations
Germany
Klinikum Hildesheim GmbH
Hildesheim, Germany
Sponsors and Collaborators
Klinikum Hildesheim GmbH
Hannover Medical School
More Information

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
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Anesthetics
Rocuronium
Bromides
Central Nervous System Depressants
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Anticonvulsants