Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation

Study Overview
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Brief Summary
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Mivacurium can be considered as an optimal choice for muscle relaxation in short duration surgeries, as butyrylcholinesterase can rapidly and reliably degrade this benzylisoquinoline muscle relaxant in vivo. However the histamine release related to a rapid high-dose injection, unsatisfactory intubation conditions and unexpected delay in recovery in patients may be encountered with butyrylcholinesterase deficiency

Detailed Description
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Intubation in emergency and full stomach patients stands as a challenge in anaesthesia. Rapid sequence induction (RSI) is the key player technique in avoiding gastric contents aspiration risk. Non-depolarizing neuromuscular blocking agents as mivacurium are of clinical significance in the anesthetic management of patient. Mivacurium has been has been preferred in situations who necessitating hemodynamic solidity all over the surgery, as only transient tachycardia and hypotension were recorded Aim of work Using high doses of mivacurium can provide accepted condition of emergency intubation within favorable time - monitoring hemodynamics changes during and after intubation, time of recovery from high doses of muscle relaxant

Official Title
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Evaluation of Effectiveness of Two Different Doses of Mivacurium in Modified Rapid Sequence Intubation for Emergency Surgery ,Prospective Randomized Double Blind Study

Conditions
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Emergencies

Intervention / Treatment
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* Drug: Mivacurium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-60 year old patients. American society of anaesthesia (ASA) 1 and 2. Emergency surgery. Exclusion Criteria: Refusal. allergy. neuromuscular disease. Suspected desaturation. Severe cardiac disease. Severe pulmonary disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized double blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Miva 3<br>Mivacurium chloride (Mivacron®) 0.3 mg/kg 3 times effective dose (ED) 95 iv during induction recording intubation condition during rapid sequence intubation within 90 sc monitoring hemodynamic changes during intubation ,time to recover to T1 | Drug: Mivacurium Chloride<br>* emergence modified sequence intubation<br>* Other names: Mivacron®;|
| Active Comparator: Miva 4<br>Mivacurium chloride (Mivacron®) 0.4 mg/kg 4 times effective dose (ED) 95 iv during induction recording intubation condition during rapid sequence intubation within 90 sc monitoring hemodynamic changes during intubation,time to recover to T1 | Drug: Mivacurium Chloride<br>* emergence modified sequence intubation<br>* Other names: Mivacron®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation conditions during RSI. | Jaw relaxation or ease blade insertion was graded as easy (3), moderate (2), difficult (1) and impossible (0). Vocal cord positions were ranked as abducted (3), moving (2), closing (1) and closed (0). Response to intubation was graded as no movement (3), slight diaphragmatic movement (2), mild coughing (1) and severe coughing or bucking (0). The total scores of the three variables were rated as excellent (8-9), good (6-7), fair (3-5) and poor (0-2). Good and excellent intubating conditions were considered 'clinically acceptable'. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in heart rate beat/minute: | pre-induction. every 1 minute for 5 minutes after intubation | 12 weeks | 
| change in mean arterial bood pressure (MAP) mmHg/minute: | pre-induction. every 1 minute for 5 minutes after intubating | 12 weeks | 
| time/minute to T1 recovery monitoring | by train-of-four (TOF) every 5 minutes until one twitch of TOF | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mivacurium, rapid sequence intubation, emergency surgery