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MyoclonusPhase 4NCT02518789

Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

A Phase 4 study testing Low-dose Dexmedetomidine, High-dose dexmedetomidine and normal saline in people with Myoclonus, run by Tang-Du Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

By observing the difference of plasma homovanillic acid concentrations and brain electrical consciousness monitoring Narcotrend index, study the possible mechanism of influencing Etomidate induced myoclonus with Dexmedetomidine pretreatment during general anesthesia induction period. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Myoclonus
What is being tested?
Low-dose Dexmedetomidine, High-dose dexmedetomidine and normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
No sites listed yet
Study dates
Sep 2015to Sep 2016
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Sign the informed consent
  • American Society of Anesthesiologists (ASA)classification:class I~II;undergoing elective surgery patients
  • Aged between 18 and 55, 49-67 kg weight
  • Body Mass Index（BMI）： 20-30 kg/m2
  • Did not use any analgesic or sedatives drugs within 24 h pre-operation

Who cannot join

  • Recently patients undergoing sedative drugs and antidepressant treatment
  • Serious vision, hearing impairment or other reasons can not communicate
  • Serious neurological disease, pregnancy, diseases of the cardiovascular system；
  • BMI is Less than the standard 80% or higher than the standard 120%

About this study

Official title: Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period

By observing the difference of plasma homovanillic acid concentrations and brain electrical consciousness monitoring Narcotrend index, study the possible mechanism of influencing Etomidate induced myoclonus with Dexmedetomidine pretreatment during general anesthesia induction period.

Conditions
Myoclonus
Being tested
Low-dose Dexmedetomidine, High-dose dexmedetomidine, normal saline, Etomidate, midazolam，fentanyl，rocuronium
Keywords
myoclonus, Etomidate, Dexmedetomidine
Medical subject headings
Myoclonus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose DexmedetomidineDrug

    Also called Yisi

    Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.

  • High-dose dexmedetomidineDrug

    Also called Yisi

    Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.

  • normal salineDrug

    Also called Sodium Chloride Physiological Solution

    Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.

  • EtomidateDrug

    Also called Fuerli

    After 90 seconds of Pretreatment，intravenous infusion of etomidate fat emulsion 0.3mg/kg.

    -Does not offer any other drugs within 5 min after completion of etomidate.

  • midazolam，fentanyl，rocuroniumDrug

    Also called Liyuexi，Fentanyl Citrate Injection，Aikesong

    Anesthesia induction：Intravenous injection midazolam 0.03 ~ 0.05 mg/kg, fentanyl 5 ~ 8 g/kg, rocuronium 0.6 mg/kg

  • propofol，remifentanil，cis atracuriumDrug

    Also called Propofol Injection，Ruifen，Cisatracurium Besylate Injection

    Anesthesia maintenance：Intravenous infusion of propofol 4 ~ 6 mg/kg/h, remifentanil 0.1 ~ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 ~ 0.1mg/kg

Study groups in NCT02518789
Study groupRoleWhat they receive
Low-dose DexmedetomidineExperimental-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
Receives: Drug: Low-dose Dexmedetomidine; Drug: Etomidate; Drug: midazolam，fentanyl，rocuronium; Drug: propofol，remifentanil，cis atracurium
High-dose DexmedetomidineExperimental-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
Receives: Drug: High-dose dexmedetomidine; Drug: Etomidate; Drug: midazolam，fentanyl，rocuronium; Drug: propofol，remifentanil，cis atracurium
normal saline Control groupPlacebo comparator-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
Receives: Drug: normal saline; Drug: Etomidate; Drug: midazolam，fentanyl，rocuronium; Drug: propofol，remifentanil，cis atracurium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. myoclonus level

    • Level 0 ：no myoclonus happened;
    • Level 1 ：mild, tiny movement, one part of the body such as a finger or shoulder movement;
    • Level 2 ：moderate ,2 pieces of different muscle or slight movement of the muscle groups, such as face or legs;
    • Level 3 ：severely, 2 pieces or more muscle contracture intensity, such as fast outreach of limbs

    Measured: when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes

  2. Plasma homovanillic acid concentration（PHVA）

    Measured: Measured when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes; if myoclonus does not appear,measured at 5 minutes after emulsion injection is completed.

Secondary outcomes (2)

  1. Ramsay sedation score

    Measured: 1 min after entering the operating room; 1 min after dexmedetomidine injection is completed; 1 min after emulsion injection is completed;5 minutes after emulsion injection is completed；

  2. Narcotrend index

    Measured: 1 min after entering the operating room; 1 min after dexmedetomidine injection is completed; 1 min after emulsion injection is completed;5 minutes after emulsion injection is completed；

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionAug 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02518789
Sponsor's protocol ID
Tangdu-Eto-myo
Status last verified
Aug 2015
First submitted
3 Aug 2015
Last updated
10 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Schwarzkopf KR, Hueter L, Simon M, Fritz HG. Midazolam pretreatment reduces etomidate-induced myoclonic movements. Anaesth Intensive Care. 2003 Feb;31(1):18-20. doi: 10.1177/0310057X0303100103.

    PubMed 12635389

  • Stockham RJ, Stanley TH, Pace NL, Gillmor S, Groen F, Hilkens P. Fentanyl pretreatment modifies anaesthetic induction with etomidate. Anaesth Intensive Care. 1988 May;16(2):171-6. doi: 10.1177/0310057X8801600207.

    PubMed 3394909

  • Doenicke AW, Roizen MF, Kugler J, Kroll H, Foss J, Ostwald P. Reducing myoclonus after etomidate. Anesthesiology. 1999 Jan;90(1):113-9. doi: 10.1097/00000542-199901000-00017.

    PubMed 9915320

  • Paris A, Philipp M, Tonner PH, Steinfath M, Lohse M, Scholz J, Hein L. Activation of alpha 2B-adrenoceptors mediates the cardiovascular effects of etomidate. Anesthesiology. 2003 Oct;99(4):889-95. doi: 10.1097/00000542-200310000-00022.

    PubMed 14508322

  • Maze M, Virtanen R, Daunt D, Banks SJ, Stover EP, Feldman D. Effects of dexmedetomidine, a novel imidazole sedative-anesthetic agent, on adrenal steroidogenesis: in vivo and in vitro studies. Anesth Analg. 1991 Aug;73(2):204-8. doi: 10.1213/00000539-199108000-00015.

    PubMed 1649559

  • Venn RM, Bryant A, Hall GM, Grounds RM. Effects of dexmedetomidine on adrenocortical function, and the cardiovascular, endocrine and inflammatory responses in post-operative patients needing sedation in the intensive care unit. Br J Anaesth. 2001 May;86(5):650-6. doi: 10.1093/bja/86.5.650.

    PubMed 11575340

  • Mizrak A, Koruk S, Bilgi M, Kocamer B, Erkutlu I, Ganidagli S, Oner U. Pretreatment with dexmedetomidine or thiopental decreases myoclonus after etomidate: a randomized, double-blind controlled trial. J Surg Res. 2010 Mar;159(1):e11-6. doi: 10.1016/j.jss.2009.07.031. Epub 2009 Aug 19.

    PubMed 20018300

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low-dose Dexmedetomidine, High-dose dexmedetomidine and normal saline in people with Myoclonus, run by Tang-Du 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Aug 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

myoclonus level (time frame: when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02518789, which also lists 7 linked publications.

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 10 Aug 2015.

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