EmergenciesRSINCT06072534
Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation
A study testing "Mivacurium Chloride" in people with Emergencies, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Emergencies
- What is being tested?
- "Mivacurium Chloride"
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-60 year old patients.
- American society of anaesthesia (ASA) 1 and 2.
- Emergency surgery.
Who cannot join
- Refusal.
- allergy.
- neuromuscular disease.
- Suspected desaturation.
- Severe cardiac disease.
- Severe pulmonary disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Azhar University
Cairo, Naser City, 11811
ahmed m selim, director, 0020222611404, info@azhar.edu.eg
About this study
Official title: Evaluation of Effectiveness of Two Different Doses of Mivacurium in Modified Rapid Sequence Intubation for Emergency Surgery ,Prospective Randomized Double Blind Study
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
Read the 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
- Conditions
- Emergencies
- Being tested
- "Mivacurium Chloride"
- Keywords
- mivacurium, rapid sequence intubation, emergency surgery
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Mivacurium Chloride"Drug
Also called "Mivacron®"
emergence modified sequence intubation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: "Mivacurium Chloride" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 3 months
Secondary outcomes (3)
change in heart rate beat/minute:
- pre-induction.
- every 1 minute for 5 minutes after intubation
Measured: 12 weeks
change in mean arterial bood pressure (MAP) mmHg/minute:
- pre-induction.
- every 1 minute for 5 minutes after intubating
Measured: 12 weeks
time/minute to T1 recovery monitoring
by train-of-four (TOF) every 5 minutes until one twitch of TOF
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Sep 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized double blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Mohamed Abdelgawad Ahmed, Al-Azhar University
- Investigators
- ismail m ahmed, professor, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072534
- Sponsor's protocol ID
- mivacurium in RSI
- Acronym
- RSI
- Status last verified
- Jan 2024
- First submitted
- 3 Sep 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the patient will be coded
Publications
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.
PubMed 2967039Ostergaard 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.
PubMed 14616318Plaud 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.
PubMed 12145055Cooper 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.
PubMed 1389845
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Two Different Doses of Mivacurium in Modified Rapid Sequence Intubation for Emergency Surgery ,Prospective Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT06072534
- Acronym / sponsor ID
- RSI / mivacurium in RSI
- Conditions
- Emergencies
- Keywords
- mivacurium, rapid sequence intubation, emergency surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized double blind
| Arm | Type | Receives |
|---|---|---|
| Miva 3 | Active comparator | Drug: "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 | Active comparator | Drug: "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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-60 year old patients.
- American society of anaesthesia (ASA) 1 and 2.
- Emergency surgery.
Key exclusion criteria (6 listed)
- Refusal.
- allergy.
- neuromuscular disease.
- Suspected desaturation.
- Severe cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Mivacurium Chloride"Also: "Mivacron®"emergence modified sequence intubation | Drug | Miva 3, Miva 4 |
Primary outcome
Intubation conditions during RSI.
Time frame: 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'.
3 secondary outcomes
change in heart rate beat/minute:
Time frame: 12 weeks
change in mean arterial bood pressure (MAP) mmHg/minute:
Time frame: 12 weeks
time/minute to T1 recovery monitoring
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 2967039Savarese 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.
- Background: PubMed 14616318Ostergaard 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.
- Background: PubMed 12145055Plaud 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.
- Background: PubMed 1389845Cooper 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.
- Individual participant dataSharing planned: No. the patient will be coded
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ismail m ahmed, professor principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Mivacurium Chloride" in people with Emergencies, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ismail m ahmed, professor (00201117310053, ismailabdelgawad.623@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation conditions during RSI. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072534, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.