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

NCT ID: NCT06072534

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-01-31

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

Conditions

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Emergencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized double blind
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double blind

Study Groups

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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

Group Type ACTIVE_COMPARATOR

"Mivacurium Chloride"

Intervention Type DRUG

emergence modified sequence intubation

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

Group Type ACTIVE_COMPARATOR

"Mivacurium Chloride"

Intervention Type DRUG

emergence modified sequence intubation

Interventions

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"Mivacurium Chloride"

emergence modified sequence intubation

Intervention Type DRUG

Other Intervention Names

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"Mivacron®"

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Mohamed Abdelgawad Ahmed

DOCTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ismail m ahmed, professor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Al Azhar University

Cairo, Naser City, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ismail m ahmed, professor

Role: CONTACT

00201117310053

Facility Contacts

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ahmed m selim, director

Role: primary

0020222611404

References

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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.

Reference Type BACKGROUND
PMID: 2967039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14616318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12145055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1389845 (View on PubMed)

Other Identifiers

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mivacurium in RSI

Identifier Type: -

Identifier Source: org_study_id

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