FasciculationPhase 3NCT02481193
Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
A Phase 3 study testing Cisatracurium in people with Fasciculation, run by Yangzhou No.1 People's Hospital.
Trial summary
The purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasciculation
- What is being tested?
- Cisatracurium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jan 2014
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia
- 20 - 65 years old
- without acid-base imbalance and electrolyte disturbance
- with normal hepatic and renal function
Who cannot join
- Patients with known hyperkalemia
- Patients with increased intraocular pressure
- Patients with increased intracranial pressure
- Patients with symptoms of gastroesophageal reflux
- Patients with anticipated airway difficulties
- Patients with malignant fever
Show all 10Show fewer
- Patients with neuromuscular disease
- Patients with burn or crush injuries
- Patients with taking drugs known to alter the action of neuromuscular blockers
- Patients with with a body mass index exceeding 30
About this study
The purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.
Read the detailed description
Purpose: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.
Methods: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before the induction, at the time of endotracheal intubation, and 5 min after intubation were recorded.
- Conditions
- Fasciculation
- Being tested
- Cisatracurium
- Keywords
- Cisatracurium, Myalgia, Fasciculation, Succinylcholine
- Medical subject headings
- Fasciculation, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisatracuriumDrug
Also called Dose
Different doses of cisatracurium pretreatment
| Study group | Role | What they receive |
|---|---|---|
| Cisatracurium 0.005 mg/kg | Experimental | The group received pretreatment of cisatracurium 0.005 mg/kg. Receives: Drug: Cisatracurium |
| Cisatracurium 0.01 mg/kg | Experimental | The group received pretreatment of cisatracurium 0.01 mg/kg Receives: Drug: Cisatracurium |
| Cisatracurium 0.02 mg/kg | Experimental | The group received pretreatment of cisatracurium 0.02 mg/kg Receives: Drug: Cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of fasciculations
Measured: After the injection of succinylcholine for 1.5 minutes
Secondary outcomes (7)
Side effects of the pretreatment of cisatracurium
Measured: At the time of three minutes after the pretreatment of cisatracurium
The time to maximal depression of twitch
Measured: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The extent to maximal depression of twitch
Measured: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The time for twitch recovery to 20% of its control value
Measured: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The grades of endotracheal intubation
Measured: At intubating time
The changes of serum potassium
Measured: After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
Myalgia at 24 hours postoperatively
Measured: At 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FasciculationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongsheng Zhang, MD, Yangzhou No.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481193
- Sponsor's protocol ID
- YZYY-610
- Status last verified
- Jun 2015
- First submitted
- 10 Jun 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
- ClinicalTrials.gov ID
- NCT02481193
- Acronym / sponsor ID
- YZYY-610
- Conditions
- Fasciculation
- Keywords
- Cisatracurium, Myalgia, Fasciculation, Succinylcholine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yangzhou No.1 People's HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Jun 2015 (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 purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.
Detailed description
Purpose: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.
Methods: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before the induction, at the time of endotracheal intubation, and 5 min after intubation were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cisatracurium 0.005 mg/kg | Experimental | Drug: CisatracuriumThe group received pretreatment of cisatracurium 0.005 mg/kg. |
| Cisatracurium 0.01 mg/kg | Experimental | Drug: CisatracuriumThe group received pretreatment of cisatracurium 0.01 mg/kg |
| Cisatracurium 0.02 mg/kg | Experimental | Drug: CisatracuriumThe group received pretreatment of cisatracurium 0.02 mg/kg |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia
- 20 - 65 years old
- without acid-base imbalance and electrolyte disturbance
- with normal hepatic and renal function
Key exclusion criteria (10 listed)
- Patients with known hyperkalemia
- Patients with increased intraocular pressure
- Patients with increased intracranial pressure
- Patients with symptoms of gastroesophageal reflux
- Patients with anticipated airway difficulties
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 |
|---|---|---|
| CisatracuriumAlso: DoseDifferent doses of cisatracurium pretreatment | Drug | Cisatracurium 0.005 mg/kg, Cisatracurium 0.01 mg/kg, Cisatracurium 0.02 mg/kg |
Primary outcome
The presence of fasciculations
Time frame: After the injection of succinylcholine for 1.5 minutes
7 secondary outcomes
Side effects of the pretreatment of cisatracurium
Time frame: At the time of three minutes after the pretreatment of cisatracurium
The time to maximal depression of twitch
Time frame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The extent to maximal depression of twitch
Time frame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The time for twitch recovery to 20% of its control value
Time frame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The grades of endotracheal intubation
Time frame: At intubating time
The changes of serum potassium
Time frame: After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
Myalgia at 24 hours postoperatively
Time frame: At 24 hours postoperatively
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 2015.
Related trials for Fasciculation
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisatracurium in people with Fasciculation, run by Yangzhou No.1 People's Hospital.
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 4 inclusion and 10 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 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The presence of fasciculations (time frame: After the injection of succinylcholine for 1.5 minutes). 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 2015.