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

NCT ID: NCT01228162

Last Updated: 2013-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Muscle Relaxation Muscle Trauma Analgetic Consumption Total Hip Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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general anaesthesia

patients receiving general anaesthesia and rocuronium bromide for muscle relaxation

Group Type EXPERIMENTAL

effect of muscle relaxation on muscle trauma, control group without relaxation

Intervention Type PROCEDURE

effect of muscle relaxation on muscle trauma, control group without relaxation

spinal anaesthesia

patients receiving spinal anaesthesia without muscle relaxation

Group Type ACTIVE_COMPARATOR

effect of muscle relaxation on muscle trauma, control group without relaxation

Intervention Type PROCEDURE

effect of muscle relaxation on muscle trauma, control group without relaxation

Interventions

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effect of muscle relaxation on muscle trauma, control group without relaxation

effect of muscle relaxation on muscle trauma, control group without relaxation

Intervention Type PROCEDURE

Eligibility Criteria

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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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Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role collaborator

Klinikum Hildesheim GmbH

OTHER

Sponsor Role lead

Responsible Party

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Dr. Jens Ebnet

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinikum Hildesheim GmbH

Hildesheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Nr. 5615 Hanover Med. School

Identifier Type: -

Identifier Source: org_study_id

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