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

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ClinicalTrials.gov Identifier: NCT04921046
Recruitment Status : Completed
First Posted : June 10, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
FIZZA BATOOL, Rawalpindi Medical College

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.


Condition or disease Intervention/treatment Phase
Myoclonic Jerk Drug: lignocaine Drug: Midazolam 1 milligram Prefilled Syringe Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two arm parallel assignment, two groups, receive two different drugs ;drug A and drug B to see the effect.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The test solutions were prepared in coded syringes and the observer was blinded to the groups as well as drugs .
Primary Purpose: Prevention
Official Title: Effect of Pretreatment of Lignocaine Versus Midazolam in the Prevention of Etomidate Induced Myoclonus
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015


Arm Intervention/treatment
Active Comparator: Group Lignocaine
Group of 112 patients ASA-I and II (American Society of Anesthesiology)ages from 25-44 undergoing elective surgical procedure.
Drug: lignocaine
After giving lignocaine to a group of people, myoclonus was observed after the dose of etomidate given two minutes after lignocaine.
Other Name: 2% lignocaine 1 ml

Active Comparator: Group Midazolam
Group of 112 patients ASA-I and II ages from 25-44 undergoing elective surgical procedure.
Drug: Midazolam 1 milligram Prefilled Syringe
after giving midazolam to the second group of people two minutes before etomidate dose, myoclonus was observed for one minute.
Other Name: Dormicum




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921046


Sponsors and Collaborators
Rawalpindi Medical College
Investigators
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Principal Investigator: Fizza Batool, FCPS Rawalpindi Medical College
Publications of Results:
Other Publications:
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

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Responsible Party: FIZZA BATOOL, Post graduate trainee Anesthesiology, Rawalpindi Medical College
ClinicalTrials.gov Identifier: NCT04921046    
Other Study ID Numbers: RMC Dissertation based article
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myoclonus
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators