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

Phase 4

Completed

• Conditions: Muscle Relaxation; Muscle Trauma; Analgetic Consumption; Total Hip Replacement
• Interventions: Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation

• Registration Number: NCT01228162
• Lead Sponsor: Klinikum Hildesheim GmbH

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-22
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anaesthesia	effect of muscle relaxation on muscle trauma, control group without relaxation	patients receiving general anaesthesia and rocuronium bromide for muscle relaxation
spinal anaesthesia	effect of muscle relaxation on muscle trauma, control group without relaxation	patients receiving spinal anaesthesia without muscle relaxation

Primary Outcome Measures

Name	Time	Method
degree of muscle trauma	24 hours	serum CK and CRP levels are measured

Secondary Outcome Measures

Name	Time	Method
consumption of analgetics	3 days	consumption of piritramide is measured

Trial Locations

Locations (1)

Klinikum Hildesheim GmbH; 🇩🇪 Hildesheim, Germany