Rapid Sequence Induction and IntubationPhase 3NCT05725031
Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment
A Phase 3 study testing Ephedrine, Rocuronium 0.6 and Rocuronium 0.8 in people with Rapid Sequence Induction and Intubation, run by Ain Shams University at 1 site in Egypt.
Trial summary
This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rapid Sequence Induction and Intubation
- What is being tested?
- Ephedrine, Rocuronium 0.6 and Rocuronium 0.8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Mar 2024
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I or II
Who cannot join
- Neuromuscular disease: myopathies
- On drugs that interact with the neuromuscular junction or ephedrine
- Cardiovascular disease: hypertension or ischemic heart disease
- Increased risk of pulmonary aspiration:
- GERD
- Pregnancy
Show all 10Show fewer
- Anticipated airway difficulties:
- Mallampati grade III or IV
- Obesity (BMI ≥30 kg/m2),
- Hypersensitivity to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium with Ephedrine Pretreatment: a Randomized Controlled Trial
This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.
- Conditions
- Rapid Sequence Induction and Intubation
- Being tested
- Ephedrine, Rocuronium 0.6, Rocuronium 0.8, Rocuronium 1.2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
70 μg/kg as pretreatment
Rocuronium 0.6Drug
0.6 mg/kg
Rocuronium 0.8Drug
0.8 mg/kg
Rocuronium 1.2Drug
1.2 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| ER6 | Experimental | to receive rocuronium 0.6 mg/kg with ephedrine pretreatment Receives: Drug: Ephedrine; Drug: Rocuronium 0.6 |
| ER8 | Experimental | to receive rocuronium 0.8 mg/kg with ephedrine pretreatment Receives: Drug: Ephedrine; Drug: Rocuronium 0.8 |
| R12 | Active comparator | to receive rocuronium 1.2 mg/kg with no pretreatment Receives: Drug: Rocuronium 1.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation conditions
Evaluation of intubation conditions after rapid sequence induction using rocuronium 0.6 or 0.8 mg/kg with ephedrine pretreatment, compared with 1.2 mg/kg, according to the criteria of the Good Clinical Research Practice (GCRP) in pharmacodynamic studies of NMBAs (Fuchs-Buder et al., 2007), which assess each of the following variables for their qualities described as: (excellent, good, poor)
- ease of laryngoscopy (easy, fair, difficult)
- vocal cords position (abducted, intermediate, closed)
- reaction to tracheal tube insertion and cuff inflation (coughing: none, slight, vigorous)
The 3 variables will be combined to describe intubation conditions as:
- Excellent: if all qualities are excellent
- Good: if all qualities are either excellent or good
- Poor: if there is a single poor quality
Measured: after 60 seconds of rocuronium administration
Secondary outcomes (2)
Heart rate
Following up the heart rate on the monitor
Measured: every minute of the first 5 minutes of intubation
Mean arterial pressure
Following up the mean arterial pressure by noninvasive blood pressure monitoring
Measured: every minute of the first 5 minutes of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Apr 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence Induction and IntubationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Ahmed Eldemohi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725031
- Sponsor's protocol ID
- Eph-Roc
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium with Ephedrine Pretreatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05725031
- Acronym / sponsor ID
- Eph-Roc
- Conditions
- Rapid Sequence Induction and Intubation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 13 Feb 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.
This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ER6 | Experimental | Drug: Ephedrine, Drug: Rocuronium 0.6to receive rocuronium 0.6 mg/kg with ephedrine pretreatment |
| ER8 | Experimental | Drug: Ephedrine, Drug: Rocuronium 0.8to receive rocuronium 0.8 mg/kg with ephedrine pretreatment |
| R12 | Active comparator | Drug: Rocuronium 1.2to receive rocuronium 1.2 mg/kg with no pretreatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status I or II
Key exclusion criteria (10 listed)
- Neuromuscular disease: myopathies
- On drugs that interact with the neuromuscular junction or ephedrine
- Cardiovascular disease: hypertension or ischemic heart disease
- Increased risk of pulmonary aspiration:
- Anticipated airway difficulties:
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 |
|---|---|---|
| Ephedrine70 μg/kg as pretreatment | Drug | ER6, ER8 |
| Rocuronium 0.60.6 mg/kg | Drug | ER6 |
| Rocuronium 0.80.8 mg/kg | Drug | ER8 |
| Rocuronium 1.21.2 mg/kg | Drug | R12 |
Primary outcome
Intubation conditions
Time frame: after 60 seconds of rocuronium administration
Evaluation of intubation conditions after rapid sequence induction using rocuronium 0.6 or 0.8 mg/kg with ephedrine pretreatment, compared with 1.2 mg/kg, according to the criteria of the Good Clinical Research Practice (GCRP) in pharmacodynamic studies of NMBAs (Fuchs-Buder et al., 2007), which assess each of the following variables for their qualities described as: (excellent, good, poor) * ease of laryngoscopy (easy, fair, difficult) * vocal cords position (abducted, intermediate, closed) * reaction to tracheal tube insertion and cuff inflation (coughing: none, slight, vigorous) The 3 variables will be combined to describe intubation conditions as: * Excellent: if all qualities are excellent * Good: if all qualities are either excellent or good * Poor: if there is a single poor quality
2 secondary outcomes
Heart rate
Time frame: every minute of the first 5 minutes of intubation
Mean arterial pressure
Time frame: every minute of the first 5 minutes of intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Anesthesia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ephedrine, Rocuronium 0.6 and Rocuronium 0.8 in people with Rapid Sequence Induction and Intubation, run by Ain Shams 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 15 Oct 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation conditions (time frame: after 60 seconds of rocuronium administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.