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

Total Hip Replacement Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228162
• Other study ID #: Nr. 5615 Hanover Med. School
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2010
• Last updated: June 22, 2013
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Klinikum Hildesheim GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hanover Medical School Germany ':'law of Germany ':'
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Analgetic Consumption
• Muscle Relaxation
• Muscle Trauma
• Total Hip Replacement

Intervention

Procedure:
• effect of muscle relaxation on muscle trauma, control group without relaxation
effect of muscle relaxation on muscle trauma, control group without relaxation

Locations

Country	Name	City	State
Germany	Klinikum Hildesheim GmbH	Hildesheim

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Hildesheim GmbH	Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of muscle trauma	serum CK and CRP levels are measured	24 hours	No
Secondary	consumption of analgetics	consumption of piritramide is measured	3 days	No