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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06072534
Acronym
RSI
Enrollment
100
Registered
2023-10-10
Start date
2023-09-01
Completion date
2024-01-31
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies

Keywords

mivacurium, rapid sequence intubation, emergency surgery

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

Interventions

emergence modified sequence intubation

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind

Intervention model description

prospective randomized double blind

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intubation conditions during RSI.3 monthsJaw 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

MeasureTime frameDescription
change in heart rate beat/minute:12 weeks* pre-induction. * every 1 minute for 5 minutes after intubation
change in mean arterial bood pressure (MAP) mmHg/minute:12 weeks* pre-induction. * every 1 minute for 5 minutes after intubating
time/minute to T1 recovery monitoring12 weeksby train-of-four (TOF) every 5 minutes until one twitch of TOF

Countries

Egypt

Contacts

Primary Contactismail m ahmed, professor
ismailabdelgawad.623@azhar.edu.eg00201117310053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026