Clinical trial NCT06072534: Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation
Official title: Evaluation of Effectiveness of Two Different Doses of Mivacurium in Modified Rapid Sequence Intubation for Emergency Surgery ,Prospective Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergencies
Keywords: mivacurium
rapid sequence intubation
emergency surgery
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized double blind
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Intubation conditions during RSI.
timeFrame: 3 months
Secondary outcomes:
measure: change in heart rate beat/minute:
timeFrame: 12 weeks
measure: change in mean arterial bood pressure (MAP) mmHg/minute:
timeFrame: 12 weeks
measure: time/minute to T1 recovery monitoring
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Naser City
Study officials:
affiliation: Al-Azhar University
name: ismail m ahmed, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savarese JJ, Ali HH, Basta SJ, Embree PB, Scott RP, Sunder N, Weakly JN, Wastila WB, el-Sayad HA. The clinical neuromuscular pharmacology of mivacurium chloride (BW B1090U). A short-acting nondepolarizing ester neuromuscular blocking drug. Anesthesiology. 1988 May;68(5):723-32. doi: 10.1097/00000542-198805000-00010.
citation: Ostergaard D, Viby-Mogensen J, Rasmussen SN, Gatke MR, Pedersen NA, Skovgaard LT. Pharmacokinetics and pharmacodynamics of mivacurium in patients phenotypically heterozygous for the usual and atypical plasma cholinesterase variants (UA). Acta Anaesthesiol Scand. 2003 Nov;47(10):1219-25. doi: 10.1046/j.1399-6576.2003.00243.x.
citation: Plaud B, Marty J, Debaene B, Meistelman C, Pellissier D, LePage JY, Feiss P, Scherpereel P, Bouverne MN, Fosse S. The cardiovascular effects of mivacurium in hypertensive patients. Anesth Analg. 2002 Aug;95(2):379-84, table of contents. doi: 10.1097/00000539-200208000-00025.
citation: Cooper R, Mirakhur RK, Clarke RS, Boules Z. Comparison of intubating conditions after administration of Org 9246 (rocuronium) and suxamethonium. Br J Anaesth. 1992 Sep;69(3):269-73. doi: 10.1093/bja/69.3.269.