Muscle RelaxationPhase 4NCT01228162
Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation
A Phase 4 study of Muscle Relaxation and Muscle Trauma, run by Klinikum Hildesheim GmbH at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Muscle Relaxation, Muscle Trauma, Analgetic Consumption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- effect of muscle relaxation on muscle trauma, control group without relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of muscle relaxation on muscle trauma, control group without relaxationProcedure or surgery
effect of muscle relaxation on muscle trauma, control group without relaxation
| Study group | Role | What they receive |
|---|---|---|
| general anaesthesia | Experimental | patients receiving general anaesthesia and rocuronium bromide for muscle relaxation Receives: Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation |
| spinal anaesthesia | Active comparator | patients receiving spinal anaesthesia without muscle relaxation Receives: Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of muscle trauma
serum CK and CRP levels are measured
Measured: 24 hours
Secondary outcomes (1)
consumption of analgetics
consumption of piritramide is measured
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Hildesheim GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Principal investigator, Dr. Jens Ebnet, Klinikum Hildesheim GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228162
- Sponsor's protocol ID
- Nr. 5615 Hanover Med. School
- Status last verified
- Jun 2013
- First submitted
- 25 Oct 2010
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation
- ClinicalTrials.gov ID
- NCT01228162
- Acronym / sponsor ID
- Nr. 5615 Hanover Med. School
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Klinikum Hildesheim GmbHUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anaesthesia | Experimental | Procedure: effect of muscle relaxation on muscle trauma, control group without relaxationpatients receiving general anaesthesia and rocuronium bromide for muscle relaxation |
| spinal anaesthesia | Active comparator | Procedure: effect of muscle relaxation on muscle trauma, control group without relaxationpatients receiving spinal anaesthesia without muscle relaxation |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patient agreement
- indication for total hip replacement
- age 55 - 80 years
- weight 65 - 95 kg
- first intervention
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| effect of muscle relaxation on muscle trauma, control group without relaxationeffect of muscle relaxation on muscle trauma, control group without relaxation | Procedure or surgery | general anaesthesia, spinal anaesthesia |
Primary outcome
degree of muscle trauma
Time frame: 24 hours
serum CK and CRP levels are measured
1 secondary outcome
consumption of analgetics
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Muscle Relaxation and Muscle Trauma, run by Klinikum Hildesheim GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of muscle trauma (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.