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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

Primary Purpose

Muscle Relaxation, Muscle Trauma, Analgetic Consumption

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
effect of muscle relaxation on muscle trauma, control group without relaxation
Sponsored by
Klinikum Hildesheim GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Relaxation

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Sites / Locations

  • Klinikum Hildesheim GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

general anaesthesia

spinal anaesthesia

Arm Description

patients receiving general anaesthesia and rocuronium bromide for muscle relaxation

patients receiving spinal anaesthesia without muscle relaxation

Outcomes

Primary Outcome Measures

degree of muscle trauma
serum CK and CRP levels are measured

Secondary Outcome Measures

consumption of analgetics
consumption of piritramide is measured

Full Information

First Posted
October 25, 2010
Last Updated
June 22, 2013
Sponsor
Klinikum Hildesheim GmbH
Collaborators
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01228162
Brief Title
Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum Hildesheim GmbH
Collaborators
Hannover Medical School

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Relaxation, Muscle Trauma, Analgetic Consumption, Total Hip Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
general anaesthesia
Arm Type
Experimental
Arm Description
patients receiving general anaesthesia and rocuronium bromide for muscle relaxation
Arm Title
spinal anaesthesia
Arm Type
Active Comparator
Arm Description
patients receiving spinal anaesthesia without muscle relaxation
Intervention Type
Procedure
Intervention Name(s)
effect of muscle relaxation on muscle trauma, control group without relaxation
Intervention Description
effect of muscle relaxation on muscle trauma, control group without relaxation
Primary Outcome Measure Information:
Title
degree of muscle trauma
Description
serum CK and CRP levels are measured
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
consumption of analgetics
Description
consumption of piritramide is measured
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient agreement indication for total hip replacement age 55 - 80 years weight 65 - 95 kg first intervention ASA classification I - III 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 -
Facility Information:
Facility Name
Klinikum Hildesheim GmbH
City
Hildesheim
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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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