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

Primary Purpose

Myoclonic Jerk

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lignocaine
Midazolam 1 milligram Prefilled Syringe
Sponsored by
Rawalpindi Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myoclonic Jerk

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group Lignocaine

    Group Midazolam

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2021
    Last Updated
    June 8, 2021
    Sponsor
    Rawalpindi Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04921046
    Brief Title
    Effect of Pretreatment of Lignocaine Versus Midazolam in Prevention of Etomidate Induced Myoclonus.
    Official Title
    Effect of Pretreatment of Lignocaine Versus Midazolam in the Prevention of Etomidate Induced Myoclonus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    June 30, 2015 (Actual)
    Study Completion Date
    June 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rawalpindi Medical College

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myoclonic Jerk

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    two arm parallel assignment, two groups, receive two different drugs ;drug A and drug B to see the effect.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    The test solutions were prepared in coded syringes and the observer was blinded to the groups as well as drugs .
    Allocation
    Randomized
    Enrollment
    224 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Lignocaine
    Arm Type
    Active Comparator
    Arm Description
    Group of 112 patients ASA-I and II (American Society of Anesthesiology)ages from 25-44 undergoing elective surgical procedure.
    Arm Title
    Group Midazolam
    Arm Type
    Active Comparator
    Arm Description
    Group of 112 patients ASA-I and II ages from 25-44 undergoing elective surgical procedure.
    Intervention Type
    Drug
    Intervention Name(s)
    lignocaine
    Other Intervention Name(s)
    2% lignocaine 1 ml
    Intervention Description
    After giving lignocaine to a group of people, myoclonus was observed after the dose of etomidate given two minutes after lignocaine.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam 1 milligram Prefilled Syringe
    Other Intervention Name(s)
    Dormicum
    Intervention Description
    after giving midazolam to the second group of people two minutes before etomidate dose, myoclonus was observed for one minute.
    Primary Outcome Measure Information:
    Title
    Occurrence and Frequency of Myoclonus
    Description
    involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
    Time Frame
    Immediately after giving etomidate dose.
    Title
    Occurrence and Frequency of Myoclonus
    Description
    involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
    Time Frame
    20 seconds after giving etomidate dose.
    Title
    Occurrence and Frequency of Myoclonus
    Description
    involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
    Time Frame
    40 seonds after giving etomidate dose.
    Title
    Occurrence and Frequency of Myoclonus
    Description
    involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.
    Time Frame
    60 seconds after giving etomidate dose.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fizza Batool, FCPS
    Organizational Affiliation
    Rawalpindi Medical College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    Effect of Pretreatment of Lignocaine Versus Midazolam in Prevention of Etomidate Induced Myoclonus.

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