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

Emergencies Clinical Trial

— RSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072534
• Other study ID #: mivacurium in RSI
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 2024

Study information

• Verified date: January 2024
• Source: Al-Azhar University
• Contact: ismail m ahmed, professor
• Phone: 00201117310053
• Email: ismailabdelgawad.623[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies

Intervention

Drug:
• "Mivacurium Chloride"
emergence modified sequence intubation

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo	Naser City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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