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

NCT06072534 | Unknown DMC

• 1 other identifier: mivacurium in RSI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Emergencies

Keywords

mivacurium; rapid sequence intubation; emergency surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in heart rate beat/minute:

  12 weeks

• change in mean arterial bood pressure (MAP) mmHg/minute:

  12 weeks

• time/minute to T1 recovery monitoring

  12 weeks

Study Arms (2)

Miva 3

ACTIVE COMPARATOR

"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"

Miva 4

ACTIVE COMPARATOR

"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"

Interventions

"Mivacurium Chloride" DRUG

emergence modified sequence intubation

Also known as: "Mivacron®"

Miva 3; Miva 4

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• year old patients.
• American society of anaesthesia (ASA) 1 and 2.
• Emergency surgery.

You may not qualify if:

• Refusal.
• allergy.
• neuromuscular disease.
• Suspected desaturation.
• Severe cardiac disease.
• Severe pulmonary disease.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Naser City, 11811, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 2967039 BACKGROUND

• 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.

  PMID: 14616318 BACKGROUND

• 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.

  PMID: 12145055 BACKGROUND

• 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.

  PMID: 1389845 BACKGROUND

MeSH Terms

Conditions

Emergencies

Interventions

Mivacurium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ismail m ahmed, professor

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ismail m ahmed, professor

CONTACT

00201117310053; ismailabdelgawad.623@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: prospective randomized double blind

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: October 10, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)