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

8 juin 2021 mis à jour par: FIZZA BATOOL, Rawalpindi Medical College

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

224

Phase

  • Phase 4

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Group Lignocaine
Group of 112 patients ASA-I and II (American Society of Anesthesiology)ages from 25-44 undergoing elective surgical procedure.
After giving lignocaine to a group of people, myoclonus was observed after the dose of etomidate given two minutes after lignocaine.
Autres noms:
  • 2% lignocaine 1 ml
Comparateur actif: Group Midazolam
Group of 112 patients ASA-I and II ages from 25-44 undergoing elective surgical procedure.
after giving midazolam to the second group of people two minutes before etomidate dose, myoclonus was observed for one minute.
Autres noms:
  • Dormicum

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Occurrence and Frequency of Myoclonus
Délai: 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.
Immediately after giving etomidate dose.
Occurrence and Frequency of Myoclonus
Délai: 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.
20 seconds after giving etomidate dose.
Occurrence and Frequency of Myoclonus
Délai: 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.
40 seonds after giving etomidate dose.
Occurrence and Frequency of Myoclonus
Délai: 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.
60 seconds after giving etomidate dose.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Fizza Batool, FCPS, Rawalpindi Medical College

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2015

Achèvement primaire (Réel)

30 juin 2015

Achèvement de l'étude (Réel)

30 juin 2015

Dates d'inscription aux études

Première soumission

27 mai 2021

Première soumission répondant aux critères de contrôle qualité

8 juin 2021

Première publication (Réel)

10 juin 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 juin 2021

Dernière vérification

1 juin 2021

Plus d'information

Termes liés à cette étude

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produit fabriqué et exporté des États-Unis.

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