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

Not Applicable

Recruiting

• Conditions: Emergencies
• Interventions: Drug: "Mivacurium Chloride"

• Registration Number: NCT06072534
• Lead Sponsor: Al-Azhar University

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

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-10
• Status Verified: 2024-01
• Primary Completion: 2024-01
• Study Completion: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Miva 3	"Mivacurium Chloride"	"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
Miva 4	"Mivacurium Chloride"	"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

Primary Outcome Measures

Name	Time	Method
Intubation conditions during RSI.	3 months	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'.

Secondary Outcome Measures

Name	Time	Method
time/minute to T1 recovery monitoring	12 weeks	by train-of-four (TOF) every 5 minutes until one twitch of TOF
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

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Naser City, Egypt