NCT01228162

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

October 25, 2010

Last Update Submit

June 22, 2013

Conditions

Muscle RelaxationMuscle TraumaAnalgetic ConsumptionTotal Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • degree of muscle trauma

    serum CK and CRP levels are measured

    24 hours

Secondary Outcomes (1)

  • consumption of analgetics

    3 days

Study Arms (2)

general anaesthesia

EXPERIMENTAL

patients receiving general anaesthesia and rocuronium bromide for muscle relaxation

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

spinal anaesthesia

ACTIVE COMPARATOR

patients receiving spinal anaesthesia without muscle relaxation

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

Interventions

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

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

general anaesthesiaspinal anaesthesia

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient agreement
  • indication for total hip replacement
  • age 55 - 80 years
  • weight 65 - 95 kg
  • first intervention
  • ASA classification I - III
  • general and spinal anaesthesia possible in this patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Hildesheim GmbH

Hildesheim, Germany

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

DE(1)