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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Egypt1 site
  • South Valley University Hospitals

    Qina, Qena Governorate, 85203

Other trials in Egypt

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.

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 groups in NCT04709315
Study groupRoleWhat they receive
saline pretreatment/succinyl group (SS group).Active comparatorpatients 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),Experimentalpatients 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.

  1. 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)
  1. heart rate

    heart rate (beats/minute) were non invasively recorded

    Measured: at induction of anesthesia, 4 and 5 minutes after intubation.

  2. 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.

  1. First posted14 Jan 2021
  2. Study start1 Oct 2020
  3. Primary completionJan 2021 (estimated)
  4. Study completionJan 2021 (estimated)

Resources

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)
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

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.

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