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

• Sponsor: Klinikum Hildesheim GmbH (Other)
• Overall Status: Completed
• CT.gov ID: NCT01228162
• Collaborator: Hannover Medical School (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 3.6

Study Details

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
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

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 [24 hours]

   serum CK and CRP levels are measured

Secondary Outcome Measures

1. consumption of analgetics [3 days]

   consumption of piritramide is measured

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Hildesheim GmbH	Hildesheim		Germany

Sponsors and Collaborators

• Klinikum Hildesheim GmbH
• Hannover Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Jens Ebnet, MD, Klinikum Hildesheim GmbH
• ClinicalTrials.gov Identifier: NCT01228162
• Other Study ID Numbers: Nr. 5615 Hanover Med. School
• First Posted: Oct 26, 2010
• Last Update Posted: Jun 25, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Jun 25, 2013