A Phase 4 interventional study of Low-dose Dexmedetomidine and High-dose dexmedetomidine in Myoclonus, sponsored by Tang-Du Hospital. Status unknown. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-08-10.
Sponsored by Tang-Du Hospital · Phase 4, Interventional, and Treatment
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.
20 studies on the registry are indexed under Myoclonus; 6 are open to participants now.
This study's planned enrollment of 132 is above the median of 50 across 11 interventional studies indexed under Myoclonus.
Browse Myoclonus studies →Tang-Du Hospital is the lead sponsor of 167 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
Drug: Low-dose Dexmedetomidine · Drug: Etomidate · Drug: midazolam，fentanyl，rocuronium · Drug: propofol，remifentanil，cis atracurium
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
Drug: High-dose dexmedetomidine · Drug: Etomidate · Drug: midazolam，fentanyl，rocuronium · Drug: propofol，remifentanil，cis atracurium
-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
Drug: normal saline · Drug: Etomidate · Drug: midazolam，fentanyl，rocuronium · Drug: propofol，remifentanil，cis atracurium
Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.
Also known as: Yisi
Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.
Also known as: Yisi
Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
Also known as: Sodium Chloride Physiological Solution
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.
Also known as: Fuerli
Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg
Also known as: Liyuexi，Fentanyl Citrate Injection，Aikesong
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
Also known as: Propofol Injection，Ruifen，Cisatracurium Besylate Injection
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
Time frame: when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes
Plasma homovanillic acid concentration（PHVA）
Time frame: 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.
Ramsay sedation score
Time frame: 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；
Narcotrend index
Time frame: 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；
No study locations are listed for this record.
The record gives a start of Sep 2015, a primary completion of Aug 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine