Rapid Sequence InductionPhase 3NCT04709315
Rapid Sequence Induction: Succinyl Choline vs Rocuronium After Pretreatment With Dexmedetomidine
A Phase 3 study testing dexemedetomidine and rocuronium and 0.9% saline and succinyl choline 1mg/ kg in people with Rapid Sequence Induction, run by South Valley University at 1 site in Egypt.
Trial summary
Background: Rapid sequence induction is a well-established anesthetic procedure used in trauma setting and patients with full stomach. Succinyl choline has the been the drug of choice, however, it carries potential risk and sometimes fatal outcome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rapid Sequence Induction
- What is being tested?
- dexemedetomidine and rocuronium and 0.9% saline and succinyl choline 1mg/ kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to Jan 2021
- 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
- American Society of Anesthesiologists (ASA) physical status I or II
- scheduled for elective surgery of more than 60 minutes duration. -
Who cannot join
- Mallampati score of III or IV
- Neuromuscular disease
- History of allergy to the studied drugs
- Malignant hyperthermia
- Patients taking anticonvulsants or aminoglycoside antibiotic
- Hepatic dysfunction
Show all 11Show fewer
- Renal dysfunction
- Cardiovascular dysfunction;
- Electrolyte imbalance
- Morbidly obese with a body mass index (BMI) more than 30 kg/m2
- Pregnant or nursing mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Standalone Succinyl Choline and Rocuronium After Pretreatment With Dexmedetomidine, in Rapid Sequence Induction.
Background: Rapid sequence induction is a well-established anesthetic procedure used in trauma setting and patients with full stomach. Succinyl choline has the been the drug of choice, however, it carries potential risk and sometimes fatal outcome. Aim of the study: to compare rocuronium after pre-treatment with Dexmedetomidine, to succinyl choline in providing excellent intubating conditions. Material and method: Patients were randomly allocated to one of two groups, of 120 each. Control (SS) group, patients received pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg was on induction. Experimental (DR) group, received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg on induction.
Read the detailed description
Rapid sequence induction (RSI) is a well-established anesthetic procedure routinely used in emergency and trauma setting, and in elective situations when there is high risk of regurgitation/aspiration The ideal neuromuscular relaxant agent used for RSI should have a quick onset of action, which is a major advantage in trauma setting as it mitigates the risk of aspiration and desaturation when endotracheal intubation should be performed as early as possible. It also should have a quick offset to ensure that if trials at endotracheal intubation were unsuccessful, there would be quick neuromuscular recovery, with return to spontaneous breathing before the patient start desaturation. Moreover, it should have minimal cardiovascular or systemic side effects.
Typically, succinyl choline has been the neuromuscular agent of choice for RSI as it has the quickest onset and offset of action compared to other muscle relaxants. However, it has potentially risky- sometimes fatal- side effects that make it far from being ideal neuromuscular blocking agent in RSI.
Owing to its fast onset of action and stable hemodynamics Rocuronium, a non-depolarizing muscle blocker, has been suggested as possible alternative to succinyl choline in RSI. The standard rocuronium intubating dose of during routine anesthesia is 0.6 mg/ kg, which results in adequate intubation conditions within 60 seconds in nearly all patients.
The recommended rocuronium intubating dose during RSI anesthesia is 1.0-1.2 mg/kg, after which optimum tracheal intubation conditions are also achieved within 60 seconds in nearly all patients. If the standard dose of 0.6 mg/ kg is given on RSI of anesthesia, it is advised to wait 90 seconds before attempting to intubate the trachea.
Nevertheless, this high dose has long duration of action and may pose a risk in patients with unpredictable difficult intubation.
Dexmedetomidine (DEX), is a selective centrally acting α 2-adrenergic receptors agonist that has been used successfully as procedural adjuvant, e.g., to minimize the stress response to laryngoscopy during endotracheal intubation and has gained popularity in the peri-operative period, due to its unique action as anxiolytic, sedative with no respiratory depression, analgesic, opioid sparing effect, and Its ability to decrease overall anesthetic requirements.
The aim of our study is to compare a combination of standard intubating dose of DEX and rocuronium (0.6 mg /kg) to succinyl choline as regard endotracheal intubation condition during RSI.
Material and method
Patients will be randomly allocated to one of two groups, of 120 each. The Dex pretreatment/ rocuronium group (DR group), and saline pretreatment/succinyl group (SS group). In the DR group, patients shall receive pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg is the intubating muscle relaxant. In the SS group, patients receive pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg is the intubating muscle relaxant. Pretreatments will be given over 10 minutes using infusion pump.
As soon as the pretreatment is completed, intravenous (IV) fentanyl 0.1 μg / kg and preoxygenation for 3 minutes with a facemask, after which anesthesia is induced with IV propofol 2 mg/ kg. Standardized intubating procedure is carried out that on loss of consciousness, the neuromuscular relaxant drug is given per protocol, and 45 seconds later the intubating anesthetist will be called in the operating room, at 50 seconds laryngoscopy is introduced and at 60 seconds, the trachea would be expectedly successfully intubated. To minimize interobserver bias, all intubations will be conducted by two designated senior consultants. No ventilation will be carried out before orotracheal intubation. No cricoid pressure shall be performed.
- Conditions
- Rapid Sequence Induction
- Being tested
- dexemedetomidine and rocuronium, 0.9% saline and succinyl choline 1mg/ kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexemedetomidine and rocuroniumDrug
In the DR group, patients received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg was the intubating muscle relaxant
0.9% saline and succinyl choline 1mg/ kgDrug
0.9% saline over 10 minutes, and succinyl choline 1mg/ kg
| Study group | Role | What they receive |
|---|---|---|
| saline pretreatment/succinyl group (SS group). | Active comparator | patients receive pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg is the intubating muscle relaxant. Receives: Drug: 0.9% saline and succinyl choline 1mg/ kg |
| Dex pretreatment/ rocuronium group (DR group), | Experimental | patients receive pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg is the intubating muscle relaxant. Receives: Drug: dexemedetomidine and rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with excellent intubating conditions
This score is based on triad of signs: how easy to insert the laryngoscope, the anatomical position of the vocal cords, and how patients react to the introduction of the laryngoscope
Measured: 60 seconds after muscle relaxant has been given
Secondary outcomes (2)
heart rate
heart rate (beats/minute) were non invasively recorded
Measured: at induction of anesthesia, 4 and 5 minutes after intubation.
mean blood pressure
mean blood pressure were non invasively recorded.
Measured: at induction, 4 and 5 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Oct 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence InductionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ossama Hamdy Salman, South Valley University
- Investigators
- ossama salman, MD, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709315
- Sponsor's protocol ID
- southvu7
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Standalone Succinyl Choline and Rocuronium After Pretreatment With Dexmedetomidine, in Rapid Sequence Induction.
- ClinicalTrials.gov ID
- NCT04709315
- Acronym / sponsor ID
- southvu7
- Conditions
- Rapid Sequence Induction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 14 Jan 2021 (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.
Background: Rapid sequence induction is a well-established anesthetic procedure used in trauma setting and patients with full stomach. Succinyl choline has the been the drug of choice, however, it carries potential risk and sometimes fatal outcome. Aim of the study: to compare rocuronium after pre-treatment with Dexmedetomidine, to succinyl choline in providing excellent intubating conditions. Material and method: Patients were randomly allocated to one of two groups, of 120 each. Control (SS) group, patients received pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg was on induction. Experimental (DR) group, received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg on induction.
Detailed description
Rapid sequence induction (RSI) is a well-established anesthetic procedure routinely used in emergency and trauma setting, and in elective situations when there is high risk of regurgitation/aspiration The ideal neuromuscular relaxant agent used for RSI should have a quick onset of action, which is a major advantage in trauma setting as it mitigates the risk of aspiration and desaturation when endotracheal intubation should be performed as early as possible. It also should have a quick offset to ensure that if trials at endotracheal intubation were unsuccessful, there would be quick neuromuscular recovery, with return to spontaneous breathing before the patient start desaturation. Moreover, it should have minimal cardiovascular or systemic side effects.
Typically, succinyl choline has been the neuromuscular agent of choice for RSI as it has the quickest onset and offset of action compared to other muscle relaxants. However, it has potentially risky- sometimes fatal- side effects that make it far from being ideal neuromuscular blocking agent in RSI.
Owing to its fast onset of action and stable hemodynamics Rocuronium, a non-depolarizing muscle blocker, has been suggested as possible alternative to succinyl choline in RSI. The standard rocuronium intubating dose of during routine anesthesia is 0.6 mg/ kg, which results in adequate intubation conditions within 60 seconds in nearly all patients.
The recommended rocuronium intubating dose during RSI anesthesia is 1.0-1.2 mg/kg, after which optimum tracheal intubation conditions are also achieved within 60 seconds in nearly all patients. If the standard dose of 0.6 mg/ kg is given on RSI of anesthesia, it is advised to wait 90 seconds before attempting to intubate the trachea.
Nevertheless, this high dose has long duration of action and may pose a risk in patients with unpredictable difficult intubation.
Dexmedetomidine (DEX), is a selective centrally acting α 2-adrenergic receptors agonist that has been used successfully as procedural adjuvant, e.g., to minimize the stress response to laryngoscopy during endotracheal intubation and has gained popularity in the peri-operative period, due to its unique action as anxiolytic, sedative with no respiratory depression, analgesic, opioid sparing effect, and Its ability to decrease overall anesthetic requirements.
The aim of our study is to compare a combination of standard intubating dose of DEX and rocuronium (0.6 mg /kg) to succinyl choline as regard endotracheal intubation condition during RSI.
Material and method
Patients will be randomly allocated to one of two groups, of 120 each. The Dex pretreatment/ rocuronium group (DR group), and saline pretreatment/succinyl group (SS group). In the DR group, patients shall receive pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg is the intubating muscle relaxant. In the SS group, patients receive pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg is the intubating muscle relaxant. Pretreatments will be given over 10 minutes using infusion pump.
As soon as the pretreatment is completed, intravenous (IV) fentanyl 0.1 μg / kg and preoxygenation for 3 minutes with a facemask, after which anesthesia is induced with IV propofol 2 mg/ kg. Standardized intubating procedure is carried out that on loss of consciousness, the neuromuscular relaxant drug is given per protocol, and 45 seconds later the intubating anesthetist will be called in the operating room, at 50 seconds laryngoscopy is introduced and at 60 seconds, the trachea would be expectedly successfully intubated. To minimize interobserver bias, all intubations will be conducted by two designated senior consultants. No ventilation will be carried out before orotracheal intubation. No cricoid pressure shall be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline pretreatment/succinyl group (SS group). | Active comparator | Drug: 0.9% saline and succinyl choline 1mg/ kgpatients receive pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg is the intubating muscle relaxant. |
| Dex pretreatment/ rocuronium group (DR group), | Experimental | Drug: dexemedetomidine and rocuroniumpatients receive pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg is the intubating muscle relaxant. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I or II
- scheduled for elective surgery of more than 60 minutes duration. -
Key exclusion criteria (11 listed)
- Mallampati score of III or IV
- Neuromuscular disease
- History of allergy to the studied drugs
- Malignant hyperthermia
- Patients taking anticonvulsants or aminoglycoside antibiotic
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 |
|---|---|---|
| dexemedetomidine and rocuroniumIn the DR group, patients received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg was the intubating muscle relaxant | Drug | Dex pretreatment/ rocuronium group (DR group), |
| 0.9% saline and succinyl choline 1mg/ kg0.9% saline over 10 minutes, and succinyl choline 1mg/ kg | Drug | saline pretreatment/succinyl group (SS group). |
Primary outcome
number of patients with excellent intubating conditions
Time frame: 60 seconds after muscle relaxant has been given
This score is based on triad of signs: how easy to insert the laryngoscope, the anatomical position of the vocal cords, and how patients react to the introduction of the laryngoscope
2 secondary outcomes
heart rate
Time frame: at induction of anesthesia, 4 and 5 minutes after intubation.
mean blood pressure
Time frame: at induction, 4 and 5 minutes after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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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.
ossama salman, MD principal investigator
South Valley University
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 dexemedetomidine and rocuronium and 0.9% saline and succinyl choline 1mg/ kg in people with Rapid Sequence Induction, run by South Valley 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 2 inclusion and 11 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 14 Jan 2021. 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?
Results are not available in the source record.
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?
number of patients with excellent intubating conditions (time frame: 60 seconds after muscle relaxant has been given). 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 14 Jan 2021.