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

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).

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement; Muscle Relaxation; Muscle Trauma; Analgetic Consumption
• Intervention / Treatment: Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hildesheim, Germany
    • Klinikum Hildesheim GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of muscle trauma	serum CK and CRP levels are measured	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consumption of analgetics	consumption of piritramide is measured	3 days

Collaborators and Investigators

• Sponsor: Klinikum Hildesheim GmbH
• Collaborators: Hannover Medical School

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (Estimate): October 26, 2010

Study Record Updates

• Last Update Posted (Estimate): June 25, 2013
• Last Update Submitted That Met QC Criteria: June 22, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Nr. 5615 Hanover Med. School