Evaluation of Effectiveness of Two Different Doses of Mivacurium in Modified Rapid Sequence Intubation for Emergency Surgery ,Prospective Randomized Double Blind Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Al-Azhar University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Intubation conditions during RSI.
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
double blind
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •20-60 year old patients.
- •American society of anaesthesia (ASA) 1 and
- •Emergency surgery.
Exclusion Criteria
- •neuromuscular disease.
- •Suspected desaturation.
- •Severe cardiac disease.
- •Severe pulmonary disease.
Arms & Interventions
Miva 3
"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
Intervention: "Mivacurium Chloride" (Drug)
Miva 4
"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
Intervention: "Mivacurium Chloride" (Drug)
Outcomes
Primary Outcomes
Intubation conditions during RSI.
Time Frame: 3 months
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'.
Secondary Outcomes
- time/minute to T1 recovery monitoring(12 weeks)
- change in heart rate beat/minute:(12 weeks)
- change in mean arterial bood pressure (MAP) mmHg/minute:(12 weeks)
Investigators
Ismail Mohamed Abdelgawad Ahmed
DOCTOR
Al-Azhar University