Myoclonic JerkPhase 4NCT04921046
Effect of Pretreatment of Lignocaine Versus Midazolam in Prevention of Etomidate Induced Myoclonus.
A Phase 4 study testing lignocaine and Midazolam 1 milligram Prefilled Syringe in people with Myoclonic Jerk, run by Rawalpindi Medical College.
Trial summary
This study is a randomized control trial and it was conducted to compare the effectiveness of pretreatment with lignocaine versus midazolam on the frequency of myoclonus associated with etomidate induction. This was conducted in Holy Family Hospital Rawalpindi in a period of 6 months. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myoclonic Jerk
- What is being tested?
- lignocaine and Midazolam 1 milligram Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2015
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA-I / ASA-II
- any gender >20-45 years
- undergoing elective surgical procedure.
Who cannot join
- Patient who refused
- those with any neurological or psychiatric disorders
- morbid obesity
- drug allergies
- pregnant patients
About this study
Official title: Effect of Pretreatment of Lignocaine Versus Midazolam in the Prevention of Etomidate Induced Myoclonus
This study is a randomized control trial and it was conducted to compare the effectiveness of pretreatment with lignocaine versus midazolam on the frequency of myoclonus associated with etomidate induction.
This was conducted in Holy Family Hospital Rawalpindi in a period of 6 months.
Read the detailed description
INTRODUCTION:
General anaesthesia is loss of consciousness induced after administration of one or more general anaesthetic agent with overall aim of inducing sleep, amnesia, analgesia and skeletal muscles relaxation. Choosing an induction agent is a very vital step in commencing general anaesthesia1. Use of sedatives can prevent or minimize potentially harmful physiologic affects of airway manipulation that include increase in heart rate, BP, and raised intracranial pressure.
Etomidate, imidazole-derived, sedative-hypnotic agent, blocks neuroexcitation by its direct action on the gamma amino butyric acid (GABA) receptor complex1.Because of its many desirable properties like rapid onset of action, profound hypnosis, minimal histamine release, hemodynamic stability, minimal respiratory depression, and favorable cerebral effects, etomidate is considered as an ideal induction agent2. Concerns with etomidate include adrenal suppression and myoclonus3, 4.
30 to 60% of unpremedicated patients develop myoclonic movements after an induction dose (0.3 mg/kg) of etomidate1. Myoclonus is described as the involuntary contraction of some muscle fibers, leading to short observable movements of the body, more pronounced with the limbs5. In emergency scenarios, myoclonus can lead to increment in the chances of regurgitation and aspiration.
Various drugs like Lignocaine, Midazolam, Magnesium, Dezocine and dexmedetomidine have been used as pretreatment for reducing myoclonus after etomidate injection but the best drug for the purpose is yet to be discovered6, 7, 8, 9. Ideally a pretreatment drug should be short-acting, should affect respiration and hemodynamic minimally, and should not prolong the recovery period.
Lignocaine belongs to amide group of local anaesthetics.Lignocaine alters signal conduction in neuronal cell membrane8. Various studies have been conducted on lignocaine being used as a pretreatment drug; before propofol induction to reduce pain or etomidate to prevent myoclonus associated with etomidateinduction6.
Midazolam, a benzodiazepine, produce a calming effect on the brain and nerves 1, 10. Its various favorable effects include antiepileptic properties, anxiolysis, sedation, reduced attention and amnesia7. In a comparative study conducted by Singh KA (initials for first and second name of the author) et al, effect of pretreatment with lignocaine, midazolam and placebo were compared in prevention of etomidate induced myoclonus and the incidence was found to be 44%, 28% and 76% respectively5 (P<0.05). However, none of these studies have been conducted in Pakistan. The basic aim of my study is to compare the effectiveness of pretreatment with Lignocaine versus Midazolam on the frequency of myoclonus associated with etomidate induction, generate data regarding the effects, so that the more effective drug can be used routinely for the prevention of myoclonus associated with etomidate induction in routine.
METHODOLOGY:
After obtaining approval from the hospital ethics committee and written informed consent, 112 patient were recruited according to selection criteria in each group. All patients were assessed a day before surgery for anaesthesia fitness. Patient were prepared by fasting (8 h for solid foods, 4 hours for clear fluids).Patient were randomly divided into two equal groups by computer-generated numbers.
Group A received 1 ml of 2% lignocaine 2 min before induction with etomidate and Group B received 1 ml (1mg) of midazolam 2 min before induction with etomidate. On reaching the operating theater, standard monitoring were placed on all the participants, which included pulse oximeter, ECG and non-invasive blood pressure. A 20 G cannula with an intravenous line was maintained with 0.9% saline. Vitals such as pulse rate, blood pressure, respiratory rate, and oxygen saturation were recorded and taken as baseline readings. All patients were then preoxygenated with 100% oxygen for 3 min. Patients were divided randomly into two groups of 112 using computer generated random numbers. Group I received 1 ml of 2% lignocaine, and group II received 1 ml of midazolam (1 mg). The test solutions were prepared in coded syringes and were administered 2 min before etomidate induction (0.3 mg/kg) by an observer who was blinded to the allocation of the groups as well as the drug given to him. The time to the loss of eyelash reflex was recorded as the onset of induction, and an additional dose of etomidate was administered if necessary. The patients were observed continuously for myoclonic movements. The time of onset and the duration of myoclonus was observed. One minute post IV injection of etomidate and the observation of myoclonus, 0.5 mg/kg succinylcholine was administered to allow endotracheal tube placement. The vitals were observed after administration of test solution, after induction, and after endotracheal intubation every minute for five minutes, then every five minutes for fifteen minutes, and then every fifteen minutes till the surgery ends. Anesthesia was maintained with isoflurane (0.5-1%) and atracurium.
Data was collected on a standardized Proforma and analyze using SPSS-17 version (Statistical package for the social sciences). Mean ± SD (standard deviation) was calculated for quantitative variables lik age, weight and BMI. Qualitative variables like gender, myoclonus wer expressed as frequencies and percentages. Chi-square was used to compare th frequency of myoclonus in two groups. A P value less than 0.05 was consider statistically significant. Effect modifiers like age and gender were controlled b stratification. Post-stratification Chi-square test was applied.
- Conditions
- Myoclonic Jerk
- Being tested
- lignocaine, Midazolam 1 milligram Prefilled Syringe
- Medical subject headings
- Myoclonus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lignocaineDrug
Also called 2% lignocaine 1 ml
After giving lignocaine to a group of people, myoclonus was observed after the dose of etomidate given two minutes after lignocaine.
Midazolam 1 milligram Prefilled SyringeDrug
Also called Dormicum
after giving midazolam to the second group of people two minutes before etomidate dose, myoclonus was observed for one minute.
| Study group | Role | What they receive |
|---|---|---|
| Group Lignocaine | Active comparator | Group of 112 patients ASA-I and II (American Society of Anesthesiology)ages from 25-44 undergoing elective surgical procedure. Receives: Drug: lignocaine |
| Group Midazolam | Active comparator | Group of 112 patients ASA-I and II ages from 25-44 undergoing elective surgical procedure. Receives: Drug: Midazolam 1 milligram Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and Frequency of Myoclonus
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
Measured: Immediately after giving etomidate dose.
Occurrence and Frequency of Myoclonus
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
Measured: 20 seconds after giving etomidate dose.
Occurrence and Frequency of Myoclonus
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
Measured: 40 seonds after giving etomidate dose.
Occurrence and Frequency of Myoclonus
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
Measured: 60 seconds after giving etomidate dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jan 2015
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Myoclonic JerkStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arm parallel assignment, two groups, receive two different drugs ;drug A and drug B to see the effect.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FIZZA BATOOL, Rawalpindi Medical College
- Investigators
- Fizza Batool, FCPS, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921046
- Sponsor's protocol ID
- RMC Dissertation based article
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devlin RJ, Kalil D. Etomidate as an Induction Agent in Sepsis. Crit Care Nurs Clin North Am. 2018 Sep;30(3):e1-e9. doi: 10.1016/j.cnc.2018.05.004. Epub 2018 Jul 13.
PubMed 30286947Malapero RJ, Zaccagnino MP, Brovman EY, Kaye AD, Urman RD. Etomidate derivatives: Novel pharmaceutical agents in anesthesia. J Anaesthesiol Clin Pharmacol. 2017 Oct-Dec;33(4):429-431. doi: 10.4103/0970-9185.222521.
PubMed 29416230Du X, Zhou C, Pan L, Li C. Effect of dexmedetomidine in preventing etomidate-induced myoclonus: a meta-analysis. Drug Des Devel Ther. 2017 Feb 8;11:365-370. doi: 10.2147/DDDT.S121979. eCollection 2017.
PubMed 28223779Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.
PubMed 21263301Apartis E, Vercueil L. To jerk or not to jerk: A clinical pathophysiology of myoclonus. Rev Neurol (Paris). 2016 Aug-Sep;172(8-9):465-476. doi: 10.1016/j.neurol.2016.07.013. Epub 2016 Aug 24.
PubMed 27568397Lang B, Zhang L, Li F, Lin Y, Zhang W, Yang C. Comparison of the efficacy and safety of remifentanil versus different pharmacological approaches on prevention of etomidate-induced myoclonus: a meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2019 May 9;13:1593-1607. doi: 10.2147/DDDT.S200200. eCollection 2019.
PubMed 31190739Gupta P, Gupta M. Comparison of different doses of intravenous lignocaine on etomidate-induced myoclonus: A prospective randomised and placebo-controlled study. Indian J Anaesth. 2018 Feb;62(2):121-126. doi: 10.4103/ija.IJA_563_17.
PubMed 29491517Sedighinejad A, Naderi Nabi B, Haghighi M, Biazar G, Imantalab V, Rimaz S, Zaridoost Z. Comparison of the Effects of Low-Dose Midazolam, Magnesium Sulfate, Remifentanil and Low-Dose Etomidate on Prevention of Etomidate-Induced Myoclonus in Orthopedic Surgeries. Anesth Pain Med. 2016 Apr 2;6(2):e35333. doi: 10.5812/aapm.35333. eCollection 2016 Apr.
PubMed 27247915Niedermirtl F, Eberhardt M, Namer B, Leffler A, Nau C, Reeh PW, Kistner K. Etomidate and propylene glycol activate nociceptive TRP ion channels. Mol Pain. 2018 Jan-Dec;14:1744806918811699. doi: 10.1177/1744806918811699. Epub 2018 Oct 22.
PubMed 30345869Wu GN, Xu HJ, Liu FF, Wu X, Zhou H. Low-Dose Ketamine Pretreatment Reduces the Incidence and Severity of Myoclonus Induced by Etomidate: A Randomized, Double-Blinded, Controlled Clinical Trial. Medicine (Baltimore). 2016 Feb;95(6):e2701. doi: 10.1097/MD.0000000000002701.
PubMed 26871805Safavi M, Honarmand A, Sahaf AS, Sahaf SM, Attari M, Payandeh M, Iazdani A, Norian N. Magnesium sulfate versus Lidocaine pretreatment for prevention of pain on etomidate injection: A randomized, double-blinded placebo controlled trial. J Res Pharm Pract. 2015 Jan-Mar;4(1):4-8. doi: 10.4103/2279-042X.150044.
PubMed 25710044Huter L, Schreiber T, Gugel M, Schwarzkopf K. Low-dose intravenous midazolam reduces etomidate-induced myoclonus: a prospective, randomized study in patients undergoing elective cardioversion. Anesth Analg. 2007 Nov;105(5):1298-302, table of contents. doi: 10.1213/01.ane.0000287248.25610.c0.
PubMed 17959958Ye Young Yang, Sae Jin Choi, Hae Ja Kim, Soo Chang Son. The effect of midazolam, fentanyl and a small dose of etomidate for prevention of myoclonus during induction of anesthesia with etomidate. Clinical Research Article. Korean J Anesthesiol. 2000;39(2):1-66-171
Singh Ka, Ruchi G, Singh KA, Kaur BT Efficacy of lignocaine versus midazolam in controlling etomidate-induced myoclonus: a randomized placebo-controlled study. Ai Shams Med J 2014;7(3):460-4
Lang B, Zhang L, Yang C, Lin Y, Zhang W, Li F. Pretreatment with lidocaine reduces both incidence and severity of etomidate-induced myoclonus: a meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2018 Oct 4;12:3311-3319. doi: 10.2147/DDDT.S174057. eCollection 2018.
PubMed 30323563
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pretreatment of Lignocaine Versus Midazolam in the Prevention of Etomidate Induced Myoclonus
- ClinicalTrials.gov ID
- NCT04921046
- Acronym / sponsor ID
- RMC Dissertation based article
- Conditions
- Myoclonic Jerk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 10 Jun 2021 (actual)
- 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.
This study is a randomized control trial and it was conducted to compare the effectiveness of pretreatment with lignocaine versus midazolam on the frequency of myoclonus associated with etomidate induction.
This was conducted in Holy Family Hospital Rawalpindi in a period of 6 months.
Detailed description
INTRODUCTION:
General anaesthesia is loss of consciousness induced after administration of one or more general anaesthetic agent with overall aim of inducing sleep, amnesia, analgesia and skeletal muscles relaxation. Choosing an induction agent is a very vital step in commencing general anaesthesia1. Use of sedatives can prevent or minimize potentially harmful physiologic affects of airway manipulation that include increase in heart rate, BP, and raised intracranial pressure.
Etomidate, imidazole-derived, sedative-hypnotic agent, blocks neuroexcitation by its direct action on the gamma amino butyric acid (GABA) receptor complex1.Because of its many desirable properties like rapid onset of action, profound hypnosis, minimal histamine release, hemodynamic stability, minimal respiratory depression, and favorable cerebral effects, etomidate is considered as an ideal induction agent2. Concerns with etomidate include adrenal suppression and myoclonus3, 4.
30 to 60% of unpremedicated patients develop myoclonic movements after an induction dose (0.3 mg/kg) of etomidate1. Myoclonus is described as the involuntary contraction of some muscle fibers, leading to short observable movements of the body, more pronounced with the limbs5. In emergency scenarios, myoclonus can lead to increment in the chances of regurgitation and aspiration.
Various drugs like Lignocaine, Midazolam, Magnesium, Dezocine and dexmedetomidine have been used as pretreatment for reducing myoclonus after etomidate injection but the best drug for the purpose is yet to be discovered6, 7, 8, 9. Ideally a pretreatment drug should be short-acting, should affect respiration and hemodynamic minimally, and should not prolong the recovery period.
Lignocaine belongs to amide group of local anaesthetics.Lignocaine alters signal conduction in neuronal cell membrane8. Various studies have been conducted on lignocaine being used as a pretreatment drug; before propofol induction to reduce pain or etomidate to prevent myoclonus associated with etomidateinduction6.
Midazolam, a benzodiazepine, produce a calming effect on the brain and nerves 1, 10. Its various favorable effects include antiepileptic properties, anxiolysis, sedation, reduced attention and amnesia7. In a comparative study conducted by Singh KA (initials for first and second name of the author) et al, effect of pretreatment with lignocaine, midazolam and placebo were compared in prevention of etomidate induced myoclonus and the incidence was found to be 44%, 28% and 76% respectively5 (P<0.05). However, none of these studies have been conducted in Pakistan. The basic aim of my study is to compare the effectiveness of pretreatment with Lignocaine versus Midazolam on the frequency of myoclonus associated with etomidate induction, generate data regarding the effects, so that the more effective drug can be used routinely for the prevention of myoclonus associated with etomidate induction in routine.
METHODOLOGY:
After obtaining approval from the hospital ethics committee and written informed consent, 112 patient were recruited according to selection criteria in each group. All patients were assessed a day before surgery for anaesthesia fitness. Patient were prepared by fasting (8 h for solid foods, 4 hours for clear fluids).Patient were randomly divided into two equal groups by computer-generated numbers.
Group A received 1 ml of 2% lignocaine 2 min before induction with etomidate and Group B received 1 ml (1mg) of midazolam 2 min before induction with etomidate. On reaching the operating theater, standard monitoring were placed on all the participants, which included pulse oximeter, ECG and non-invasive blood pressure. A 20 G cannula with an intravenous line was maintained with 0.9% saline. Vitals such as pulse rate, blood pressure, respiratory rate, and oxygen saturation were recorded and taken as baseline readings. All patients were then preoxygenated with 100% oxygen for 3 min. Patients were divided randomly into two groups of 112 using computer generated random numbers. Group I received 1 ml of 2% lignocaine, and group II received 1 ml of midazolam (1 mg). The test solutions were prepared in coded syringes and were administered 2 min before etomidate induction (0.3 mg/kg) by an observer who was blinded to the allocation of the groups as well as the drug given to him. The time to the loss of eyelash reflex was recorded as the onset of induction, and an additional dose of etomidate was administered if necessary. The patients were observed continuously for myoclonic movements. The time of onset and the duration of myoclonus was observed. One minute post IV injection of etomidate and the observation of myoclonus, 0.5 mg/kg succinylcholine was administered to allow endotracheal tube placement. The vitals were observed after administration of test solution, after induction, and after endotracheal intubation every minute for five minutes, then every five minutes for fifteen minutes, and then every fifteen minutes till the surgery ends. Anesthesia was maintained with isoflurane (0.5-1%) and atracurium.
Data was collected on a standardized Proforma and analyze using SPSS-17 version (Statistical package for the social sciences). Mean ± SD (standard deviation) was calculated for quantitative variables lik age, weight and BMI. Qualitative variables like gender, myoclonus wer expressed as frequencies and percentages. Chi-square was used to compare th frequency of myoclonus in two groups. A P value less than 0.05 was consider statistically significant. Effect modifiers like age and gender were controlled b stratification. Post-stratification Chi-square test was applied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two arm parallel assignment, two groups, receive two different drugs ;drug A and drug B to see the effect.
| Arm | Type | Receives |
|---|---|---|
| Group Lignocaine | Active comparator | Drug: lignocaineGroup of 112 patients ASA-I and II (American Society of Anesthesiology)ages from 25-44 undergoing elective surgical procedure. |
| Group Midazolam | Active comparator | Drug: Midazolam 1 milligram Prefilled SyringeGroup of 112 patients ASA-I and II ages from 25-44 undergoing elective surgical procedure. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA-I / ASA-II
- any gender >20-45 years
- undergoing elective surgical procedure.
Key exclusion criteria (5 listed)
- Patient who refused
- those with any neurological or psychiatric disorders
- morbid obesity
- drug allergies
- pregnant patients
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 |
|---|---|---|
| lignocaineAlso: 2% lignocaine 1 mlAfter giving lignocaine to a group of people, myoclonus was observed after the dose of etomidate given two minutes after lignocaine. | Drug | Group Lignocaine |
| Midazolam 1 milligram Prefilled SyringeAlso: Dormicumafter giving midazolam to the second group of people two minutes before etomidate dose, myoclonus was observed for one minute. | Drug | Group Midazolam |
Primary outcome
Occurrence and Frequency of Myoclonus
Time frame: Immediately after giving etomidate dose.
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
Occurrence and Frequency of Myoclonus
Time frame: 20 seconds after giving etomidate dose.
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
Occurrence and Frequency of Myoclonus
Time frame: 40 seonds after giving etomidate dose.
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
Occurrence and Frequency of Myoclonus
Time frame: 60 seconds after giving etomidate dose.
involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
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 10 Jun 2021.
- Background: PubMed 30286947Devlin RJ, Kalil D. Etomidate as an Induction Agent in Sepsis. Crit Care Nurs Clin North Am. 2018 Sep;30(3):e1-e9. doi: 10.1016/j.cnc.2018.05.004. Epub 2018 Jul 13.
- Background: PubMed 29416230Malapero RJ, Zaccagnino MP, Brovman EY, Kaye AD, Urman RD. Etomidate derivatives: Novel pharmaceutical agents in anesthesia. J Anaesthesiol Clin Pharmacol. 2017 Oct-Dec;33(4):429-431. doi: 10.4103/0970-9185.222521.
- Background: PubMed 28223779Du X, Zhou C, Pan L, Li C. Effect of dexmedetomidine in preventing etomidate-induced myoclonus: a meta-analysis. Drug Des Devel Ther. 2017 Feb 8;11:365-370. doi: 10.2147/DDDT.S121979. eCollection 2017.
- Background: PubMed 21263301Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.
- Background: PubMed 27568397Apartis E, Vercueil L. To jerk or not to jerk: A clinical pathophysiology of myoclonus. Rev Neurol (Paris). 2016 Aug-Sep;172(8-9):465-476. doi: 10.1016/j.neurol.2016.07.013. Epub 2016 Aug 24.
- Background: PubMed 31190739Lang B, Zhang L, Li F, Lin Y, Zhang W, Yang C. Comparison of the efficacy and safety of remifentanil versus different pharmacological approaches on prevention of etomidate-induced myoclonus: a meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2019 May 9;13:1593-1607. doi: 10.2147/DDDT.S200200. eCollection 2019.
- Background: PubMed 29491517Gupta P, Gupta M. Comparison of different doses of intravenous lignocaine on etomidate-induced myoclonus: A prospective randomised and placebo-controlled study. Indian J Anaesth. 2018 Feb;62(2):121-126. doi: 10.4103/ija.IJA_563_17.
- Background: PubMed 27247915Sedighinejad A, Naderi Nabi B, Haghighi M, Biazar G, Imantalab V, Rimaz S, Zaridoost Z. Comparison of the Effects of Low-Dose Midazolam, Magnesium Sulfate, Remifentanil and Low-Dose Etomidate on Prevention of Etomidate-Induced Myoclonus in Orthopedic Surgeries. Anesth Pain Med. 2016 Apr 2;6(2):e35333. doi: 10.5812/aapm.35333. eCollection 2016 Apr.
- Background: PubMed 30345869Niedermirtl F, Eberhardt M, Namer B, Leffler A, Nau C, Reeh PW, Kistner K. Etomidate and propylene glycol activate nociceptive TRP ion channels. Mol Pain. 2018 Jan-Dec;14:1744806918811699. doi: 10.1177/1744806918811699. Epub 2018 Oct 22.
- Background: PubMed 26871805Wu GN, Xu HJ, Liu FF, Wu X, Zhou H. Low-Dose Ketamine Pretreatment Reduces the Incidence and Severity of Myoclonus Induced by Etomidate: A Randomized, Double-Blinded, Controlled Clinical Trial. Medicine (Baltimore). 2016 Feb;95(6):e2701. doi: 10.1097/MD.0000000000002701.
- Background: PubMed 25710044Safavi M, Honarmand A, Sahaf AS, Sahaf SM, Attari M, Payandeh M, Iazdani A, Norian N. Magnesium sulfate versus Lidocaine pretreatment for prevention of pain on etomidate injection: A randomized, double-blinded placebo controlled trial. J Res Pharm Pract. 2015 Jan-Mar;4(1):4-8. doi: 10.4103/2279-042X.150044.
- Background: PubMed 17959958Huter L, Schreiber T, Gugel M, Schwarzkopf K. Low-dose intravenous midazolam reduces etomidate-induced myoclonus: a prospective, randomized study in patients undergoing elective cardioversion. Anesth Analg. 2007 Nov;105(5):1298-302, table of contents. doi: 10.1213/01.ane.0000287248.25610.c0.
- Individual participant dataSharing planned: No
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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.
Fizza Batool, FCPS principal investigator
Rawalpindi Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lignocaine and Midazolam 1 milligram Prefilled Syringe in people with Myoclonic Jerk, run by Rawalpindi Medical College.
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 3 inclusion and 5 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 10 Jun 2021. 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 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?
Occurrence and Frequency of Myoclonus (time frame: Immediately after giving etomidate dose.). The study lists 4 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 NCT04921046, which also lists 16 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 Jun 2021.