PainNCT00986583
Effect of Succinylcholine on Patients Using Statins
A study testing Succinylcholine in people with Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Succinylcholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery
- ASA Physical Status 1-3
Who cannot join
- History of liver failure
- History of renal failure
- History of neuromuscular disease
- Increased intraocular pressure
- Recent major burn
- Multiple trauma
- Susceptibility to or family history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
About this study
Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.
- Conditions
- Pain
- Being tested
- Succinylcholine
- Keywords
- Succinylcholine, Statins, myalgias, statins with succinylcholine and pain
- Medical subject headings
- Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccinylcholineDrug
Succinylcholine will be administered pre-induction over a period of 5 seconds
| Study group | Role | What they receive |
|---|---|---|
| Statin use group | Other | Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. Receives: Drug: Succinylcholine |
| non statin use | Other | Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. Receives: Drug: Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Myoglobin Concentration
Measured: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively
Secondary outcomes (5)
Muscle Pain
verbal rating scale score and the pain score both at 2 and 24 hours postoperatively.
The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable).
The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain.
Measured: 2 and 24 hours postoperatively
Serum Potassium Concentration
Measured: At 5 and 20 min after succinylcholine
Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively
Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively
Measured: 2 and 24 hours postoperatively
Duration of Succinylcholine Block
Time required to reach maximum block by succinylcholine after succinylcholine administration.
Measured: intraoperative: from succinylcholine administration
Fasciculation
The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities.
Measured: postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Turan, The Cleveland Clinic
- Investigators
- Alparsan Turan, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986583
- Sponsor's protocol ID
- 09-683
- Status last verified
- Aug 2016
- First submitted
- 23 Sep 2009
- Last updated
- 3 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Succinylcholine on Patients Using Statins
- ClinicalTrials.gov ID
- NCT00986583
- Acronym / sponsor ID
- 09-683
- Conditions
- Pain
- Keywords
- Succinylcholine, Statins, myalgias, statins with succinylcholine and pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Posted 2 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin use group | Other | Drug: SuccinylcholinePatients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. |
| non statin use | Other | Drug: SuccinylcholinePatients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery
- ASA Physical Status 1-3
Key exclusion criteria (7 listed)
- History of liver failure
- History of renal failure
- History of neuromuscular disease
- Increased intraocular pressure
- Recent major burn
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 |
|---|---|---|
| SuccinylcholineSuccinylcholine will be administered pre-induction over a period of 5 seconds | Drug | Statin use group, non statin use |
Primary outcome
Plasma Myoglobin Concentration
Time frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively
5 secondary outcomes
Muscle Pain
Time frame: 2 and 24 hours postoperatively
Serum Potassium Concentration
Time frame: At 5 and 20 min after succinylcholine
Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively
Time frame: 2 and 24 hours postoperatively
Duration of Succinylcholine Block
Time frame: intraoperative: from succinylcholine administration
Fasciculation
Time frame: postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
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.
Alparsan Turan, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Succinylcholine in people with Pain, run by The Cleveland Clinic at 1 site in United States.
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 2 inclusion and 7 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 3 Oct 2016. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Myoglobin Concentration (time frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively). 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 3 Oct 2016.