Effect of Pretreatment of Lignocaine Versus Midazolam in Prevention of Etomidate Induced Myoclonus.

NCT04921046 | Completed Phase 4 DMC

• 1 other identifier: RMC Dissertation based article
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myoclonic Jerk

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  60 seconds after giving etomidate dose.

Study Arms (2)

Group Lignocaine

ACTIVE COMPARATOR

Group of 112 patients ASA-I and II (American Society of Anesthesiology)ages from 25-44 undergoing elective surgical procedure.

Drug: lignocaine

Group Midazolam

ACTIVE COMPARATOR

Group of 112 patients ASA-I and II ages from 25-44 undergoing elective surgical procedure.

Drug: Midazolam 1 milligram Prefilled Syringe

Interventions

lignocaine DRUG

After giving lignocaine to a group of people, myoclonus was observed after the dose of etomidate given two minutes after lignocaine.

Also known as: 2% lignocaine 1 ml

Group Lignocaine

Midazolam 1 milligram Prefilled Syringe DRUG

after giving midazolam to the second group of people two minutes before etomidate dose, myoclonus was observed for one minute.

Also known as: Dormicum

Group Midazolam

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA-I / ASA-II
• any gender \>20-45 years
• undergoing elective surgical procedure.

You may not qualify if:

• Patient who refused
• those with any neurological or psychiatric disorders
• morbid obesity
• drug allergies
• pregnant patients

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Related Publications (16)

• 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.

  PMID: 30286947 BACKGROUND

• Malapero 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.

  PMID: 29416230 BACKGROUND

• Du 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.

  PMID: 28223779 BACKGROUND

• Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.

  PMID: 21263301 BACKGROUND

• Apartis 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.

  PMID: 27568397 BACKGROUND

• Lang 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.

  PMID: 31190739 BACKGROUND

• Gupta 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.

  PMID: 29491517 BACKGROUND

• Sedighinejad 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.

  PMID: 27247915 BACKGROUND

• Niedermirtl 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.

  PMID: 30345869 BACKGROUND

• Wu 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.

  PMID: 26871805 BACKGROUND

• Safavi 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.

  PMID: 25710044 BACKGROUND

• Huter 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.

  PMID: 17959958 BACKGROUND

• Ye 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

  BACKGROUND

• 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

  RESULT

• 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.

  PMID: 30323563 RESULT

• 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.

  PMID: 12635389 RESULT

MeSH Terms

Conditions

Myoclonus

Interventions

Lidocaine; Midazolam

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fizza Batool, FCPS

  Rawalpindi Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The test solutions were prepared in coded syringes and the observer was blinded to the groups as well as drugs .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate trainee Anesthesiology

Model Details: two arm parallel assignment, two groups, receive two different drugs ;drug A and drug B to see the effect.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 10, 2021
• Study Start: January 1, 2015
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share