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Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation (RSI)

Primary Purpose

Emergencies

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
"Mivacurium Chloride"
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergencies focused on measuring mivacurium, rapid sequence intubation, emergency surgery

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al Azhar UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Miva 3

Miva 4

Arm Description

"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

"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

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2023
Last Updated
October 5, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT06072534
Brief Title
Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
mivacurium, rapid sequence intubation, emergency surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized double blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Miva 3
Arm Type
Active Comparator
Arm Description
"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
Arm Title
Miva 4
Arm Type
Active Comparator
Arm Description
"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
Intervention Type
Drug
Intervention Name(s)
"Mivacurium Chloride"
Other Intervention Name(s)
"Mivacron®"
Intervention Description
emergence modified sequence intubation
Primary Outcome Measure Information:
Title
Intubation conditions during RSI.
Description
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'.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change in heart rate beat/minute:
Description
pre-induction. every 1 minute for 5 minutes after intubation
Time Frame
12 weeks
Title
change in mean arterial bood pressure (MAP) mmHg/minute:
Description
pre-induction. every 1 minute for 5 minutes after intubating
Time Frame
12 weeks
Title
time/minute to T1 recovery monitoring
Description
by train-of-four (TOF) every 5 minutes until one twitch of TOF
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ismail m ahmed, professor
Phone
00201117310053
Email
ismailabdelgawad.623@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ismail m ahmed, professor
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Azhar University
City
Cairo
State/Province
Naser City
ZIP/Postal Code
11811
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed m selim, director
Phone
0020222611404
Email
info@azhar.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the patient will be coded
Citations:
PubMed Identifier
2967039
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.
Results Reference
background
PubMed Identifier
14616318
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.
Results Reference
background
PubMed Identifier
12145055
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.
Results Reference
background
PubMed Identifier
1389845
Citation
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.
Results Reference
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Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation

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