IntubationPhase 4NCT06409377
Effect of Dexmedetomidine on Improving Intubating Conditions Without the Use of Muscle Relaxant
A Phase 4 study testing Precedex 200 MCG in 2 ML Injection and C group: in people with Intubation and Muscle Relaxation, run by Theodor Bilharz Research Institute at 2 sites in Egypt.
Trial summary
Tracheal intubation is usually facilitated by the administration of anesthetic drugs including a muscle relaxant. Over the past few years, several factors have led researchers to consider omitting neuromuscular blocking agents for tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation, Muscle Relaxation, Dexmedetomidine
- What is being tested?
- Precedex 200 MCG in 2 ML Injection and C group:
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Feb 2024to 2 May 2024
- Phase
- Phase 4
- 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, II.
- Age 18- 60 years old of both sexes.
- Mallampati I, II
- Patients undergoing elective surgery under general anesthesia and tracheal intubation.
Who cannot join
- Age < 18 years and ≥ 60 years
- Pregnancy
- Emergency surgery or full stomach
- Mallampati III , IV
- Renal or Hepatic patients
- Patients with any cardiac condition
Show all 10Show fewer
- Patients with suspected difficult airway; e.g., high neck circumference, high body mass index (≥30 kg/m2), airway masses, mouth scars, neck scars, limited neck extension or history of snoring.
- Any patient on regular intake of beta blockers or calcium channel blockers
- Patients with any known hypersensitivity or contraindication to dexmedetomidine,
- Patients with significant neurological, psychiatric, or neuromuscular disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Theodor Bilharz research institute
Cairo, 020
Theodor Bilharz research institute
Cairo, 02
About this study
Tracheal intubation is usually facilitated by the administration of anesthetic drugs including a muscle relaxant. Over the past few years, several factors have led researchers to consider omitting neuromuscular blocking agents for tracheal intubation. (1, 2) Despite the frequent use of NMBAs in clinical practice, side effects associated with NMBA use can be particularly concerning such as anaphylaxis, cardiovascular effects related to histamine release or sympathomimetic properties, Bronchospasm, and prolonged paralysis. (3) Therefore, many studies (4, 5) focused on the possibility of performing tracheal intubation without the use of neuromuscular blocking agents. The challenge was to find the correct choice and dose of induction agent, opioid, or adjuvant drug to produce adequate intubating conditions without cardiovascular side effects. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation.
Read the detailed description
Methods: the study is designed to be prospective randomized double blinded study. 74 ASA I, II patients will be divided into 2 groups group D and group C, 37 patients in each group. Group D will receive single dose of dexmedetomidine 1.5 mcg /kg in 50 ml normal saline over 10 min IV infusion and Group C will receive 50 ml normal saline over 10 min IV infusion. Intravenous induction of anesthesia will be done using propofol (2 mg/Kg), fentanyl (1 mcg/Kg) and atracurium (0.5 mg/Kg) in the control group versus propofol (2 mg/Kg), fentanyl (1 mg/kg) and normal saline in the dexmedetomidine group. After 2 minutes of mask ventilation with 2% sevoflurane, endotracheal intubation (ETI) with 7.5mm endotracheal tube for male patients and a 7mm endotracheal tube for female patients will be performed by an experienced anesthiolgist Base line readings including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP),) will be recorded and continuous measurements will be recorded till 5 minutes after intubation. Scoring of Intubation Conditions as follows: Intubation conditions will be evaluated using a scoring system, which includes 5 factors:
score 1 2 3 4 Laryngoscope: Easy Fair Difficult Impossible Vocal cords: Open Moving Closing Closed Coughing: None Slight Moderate Severe Jaw Relaxation: Complete Slight Stiff Rigid Limb movement: None Slight Moderate Severe
The score was interpreted into 3 categories: excellent, acceptable and poor conditions:
- Excellent conditions: received a score of 1 for all the 5 factors.
- Acceptable conditions: received a score of 2 for any of the 5 factors.
- Poor conditions received a score >2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.
- Conditions
- Intubation, Muscle Relaxation, Dexmedetomidine
- Being tested
- Precedex 200 MCG in 2 ML Injection, C group:
- Keywords
- Dexmedetomidine, Intubating conditions, No muscle relaxant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precedex 200 MCG in 2 ML InjectionDrug
Also called C group: Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).
Patients received dexmedetomidine (1.5 μg/kg) as single injection over 10 minutes.
C group:Other
Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| The Dexmedetomidine Group (D) | Experimental | Patients received dexmedetomidine (1.5 μg/kg), propofol (2mg/kg), and fentanyl (1 μg/kg). Receives: Drug: Precedex 200 MCG in 2 ML Injection |
| The Control Group (C) | Placebo comparator | Patients received normal saline of volume over 10 minutes. Receives: Other: C group: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful intubations which was defined as both excellent and acceptable conditions.
- Excellent conditions: received a score of 1 for all the 5 factors.
- Acceptable conditions: received a score of 2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.
- Excellent conditions: received a score of 1 for all the 5 factors.
- Acceptable conditions: received a score of 2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start25 Feb 2024
- Primary completion30 Apr 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients was allocated according to the randomly generated numbers into 2 groups; 37 patients in each group. The Dexmedetomidine Group (D): Patients received dexmedetomidine (1.5 μg/kg), propofol (2mg/kg), and fentanyl (1 μg/kg). The Control Group (C): Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409377
- Sponsor's protocol ID
- PT (822)
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Improving Intubating Conditions Without the Use of Muscle Relaxant
- ClinicalTrials.gov ID
- NCT06409377
- Acronym / sponsor ID
- PT (822)
- Conditions
- Intubation, Muscle Relaxation, Dexmedetomidine
- Keywords
- Dexmedetomidine, Intubating conditions, No muscle relaxant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 10 May 2024 (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.
Tracheal intubation is usually facilitated by the administration of anesthetic drugs including a muscle relaxant. Over the past few years, several factors have led researchers to consider omitting neuromuscular blocking agents for tracheal intubation. (1, 2) Despite the frequent use of NMBAs in clinical practice, side effects associated with NMBA use can be particularly concerning such as anaphylaxis, cardiovascular effects related to histamine release or sympathomimetic properties, Bronchospasm, and prolonged paralysis. (3) Therefore, many studies (4, 5) focused on the possibility of performing tracheal intubation without the use of neuromuscular blocking agents. The challenge was to find the correct choice and dose of induction agent, opioid, or adjuvant drug to produce adequate intubating conditions without cardiovascular side effects. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation.
Detailed description
Methods: the study is designed to be prospective randomized double blinded study. 74 ASA I, II patients will be divided into 2 groups group D and group C, 37 patients in each group. Group D will receive single dose of dexmedetomidine 1.5 mcg /kg in 50 ml normal saline over 10 min IV infusion and Group C will receive 50 ml normal saline over 10 min IV infusion. Intravenous induction of anesthesia will be done using propofol (2 mg/Kg), fentanyl (1 mcg/Kg) and atracurium (0.5 mg/Kg) in the control group versus propofol (2 mg/Kg), fentanyl (1 mg/kg) and normal saline in the dexmedetomidine group. After 2 minutes of mask ventilation with 2% sevoflurane, endotracheal intubation (ETI) with 7.5mm endotracheal tube for male patients and a 7mm endotracheal tube for female patients will be performed by an experienced anesthiolgist Base line readings including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP),) will be recorded and continuous measurements will be recorded till 5 minutes after intubation. Scoring of Intubation Conditions as follows: Intubation conditions will be evaluated using a scoring system, which includes 5 factors:
score 1 2 3 4 Laryngoscope: Easy Fair Difficult Impossible Vocal cords: Open Moving Closing Closed Coughing: None Slight Moderate Severe Jaw Relaxation: Complete Slight Stiff Rigid Limb movement: None Slight Moderate Severe
The score was interpreted into 3 categories: excellent, acceptable and poor conditions:
- Excellent conditions: received a score of 1 for all the 5 factors.
- Acceptable conditions: received a score of 2 for any of the 5 factors.
- Poor conditions received a score >2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.
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
- Patients was allocated according to the randomly generated numbers into 2 groups; 37 patients in each group. The Dexmedetomidine Group (D): Patients received dexmedetomidine (1.5 μg/kg), propofol (2mg/kg), and fentanyl (1 μg/kg). The Control Group (C): Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).
| Arm | Type | Receives |
|---|---|---|
| The Dexmedetomidine Group (D) | Experimental | Drug: Precedex 200 MCG in 2 ML InjectionPatients received dexmedetomidine (1.5 μg/kg), propofol (2mg/kg), and fentanyl (1 μg/kg). |
| The Control Group (C) | Placebo comparator | Other: C group:Patients received normal saline of volume over 10 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I, II.
- Age 18- 60 years old of both sexes.
- Mallampati I, II
- Patients undergoing elective surgery under general anesthesia and tracheal intubation.
Key exclusion criteria (10 listed)
- Age < 18 years and ≥ 60 years
- Pregnancy
- Emergency surgery or full stomach
- Mallampati III , IV
- Renal or Hepatic patients
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 |
|---|---|---|
| Precedex 200 MCG in 2 ML InjectionAlso: C group: Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).Patients received dexmedetomidine (1.5 μg/kg) as single injection over 10 minutes. | Drug | The Dexmedetomidine Group (D) |
| C group:Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg). | Other | The Control Group (C) |
Primary outcome
Rate of successful intubations which was defined as both excellent and acceptable conditions.
Time frame: 15 minutes
* Excellent conditions: received a score of 1 for all the 5 factors. * Acceptable conditions: received a score of 2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations. * Excellent conditions: received a score of 1 for all the 5 factors. * Acceptable conditions: received a score of 2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.
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 13 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Precedex 200 MCG in 2 ML Injection and C group: in people with Intubation and Muscle Relaxation, run by Theodor Bilharz Research Institute at 2 sites 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 4 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Rate of successful intubations which was defined as both excellent and acceptable conditions. (time frame: 15 minutes). 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 13 May 2024.