General AnesthesiaNCT06573957
Comparison of the Effects of Dexmedetomidine and Lidocaine on Blood Pressure and Heart Rate Response
A study testing Dexmedetomidine and Lidocain in people with General Anesthesia, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Endotracheal intubation is considered a definitive therapy and the gold standard for airway management. However, this procedure carries several risks, including sudden increases in blood pressure and heart rate. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Dexmedetomidine and Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 May 2024to 14 Aug 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-59 years.
- Patients scheduled for oral intubation.
- Physical status ASA I and II (American Society of Anesthesiologists).
- Patients with Mallampati classification I-II.
Who cannot join
- History of allergy to the drugs that will be used.
- Pregnant patients.
- Patients taking medications that affect blood pressure and heart rate, such as vasodilators, adrenergic blockers, antiarrhythmics, and cardiac stimulants.
- Patients with arrhythmias, AV block, liver disorders, hypertension, and hypoalbuminemia.
- Patients who have been given opioids within the last 24 hours.
- Patients with predicted intubation difficulties.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Intravenous Administration of Dexmedetomidine 0.5 μg/kg Body Weight With Intravenous Lidocaine 1.5 mg/kg Body Weight on Blood Pressure and Heart Rate Response During Laryngoscopy and Endotracheal Intubation
Endotracheal intubation is considered a definitive therapy and the gold standard for airway management. However, this procedure carries several risks, including sudden increases in blood pressure and heart rate. These spikes in blood pressure and heart rate can be tolerated by healthy individuals, but for patients with cerebrovascular and cardiovascular risk factors, they can be extremely dangerous and even life-threatening. Various techniques and drug choices can be employed to prevent the hemodynamic surges associated with endotracheal intubation, including the use of anesthetic drugs from the α2-adrenergic agonist and amide classes. One of the α2-adrenergic agonists commonly used to prevent hemodynamic surges during endotracheal intubation is dexmedetomidine, while one of the amide drugs frequently used for this purpose is lidocaine.
Read the detailed description
Dexmedetomidine works very selectively on noradrenergic receptors distributed both within and outside the central nervous system, particularly in the pons and medulla. Presynaptic stimulation of α2 receptors can reduce the release of norepinephrine and the activation of postsynaptic α2 receptors. Lidocaine works by inhibiting sodium channels within cells, preventing the occurrence of action potentials and the transmission of impulses along nerves. Lidocaine also acts by blocking calcium and potassium channels as well as N-methyl-D-aspartate (NMDA) receptors.
- Conditions
- General Anesthesia
- Being tested
- Dexmedetomidine, Lidocain
- Keywords
- Haemodynamic Response, Endotracheal Intubation, Dexmedetomidine, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patient in experimental arms will received intravenous dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before general anesthesia induction
LidocainDrug
Patient in experimental arms will receive intravenous lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Twenty-one patients are administered dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before induction, then receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set. Receives: Drug: Dexmedetomidine |
| Lidocaine | Active comparator | Twenty-one patients receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set, followed by lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation. Receives: Drug: Lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured: Right after endotracheal intubation until 5 minutes after endotracheal intubation
Diastolic blood pressure
Measured: Right after endotracheal intubation until 5 minutes after endotracheal intubation
Heart rate
Measured: Right after endotracheal intubation until 5 minutes after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start29 May 2024
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573957
- Sponsor's protocol ID
- AN-202408.01
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Intravenous Administration of Dexmedetomidine 0.5 μg/kg Body Weight With Intravenous Lidocaine 1.5 mg/kg Body Weight on Blood Pressure and Heart Rate Response During Laryngoscopy and Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT06573957
- Acronym / sponsor ID
- AN-202408.01
- Conditions
- General Anesthesia
- Keywords
- Haemodynamic Response, Endotracheal Intubation, Dexmedetomidine, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 27 Aug 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.
Endotracheal intubation is considered a definitive therapy and the gold standard for airway management. However, this procedure carries several risks, including sudden increases in blood pressure and heart rate. These spikes in blood pressure and heart rate can be tolerated by healthy individuals, but for patients with cerebrovascular and cardiovascular risk factors, they can be extremely dangerous and even life-threatening. Various techniques and drug choices can be employed to prevent the hemodynamic surges associated with endotracheal intubation, including the use of anesthetic drugs from the α2-adrenergic agonist and amide classes. One of the α2-adrenergic agonists commonly used to prevent hemodynamic surges during endotracheal intubation is dexmedetomidine, while one of the amide drugs frequently used for this purpose is lidocaine.
Detailed description
Dexmedetomidine works very selectively on noradrenergic receptors distributed both within and outside the central nervous system, particularly in the pons and medulla. Presynaptic stimulation of α2 receptors can reduce the release of norepinephrine and the activation of postsynaptic α2 receptors. Lidocaine works by inhibiting sodium channels within cells, preventing the occurrence of action potentials and the transmission of impulses along nerves. Lidocaine also acts by blocking calcium and potassium channels as well as N-methyl-D-aspartate (NMDA) receptors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineTwenty-one patients are administered dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before induction, then receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set. |
| Lidocaine | Active comparator | Drug: LidocainTwenty-one patients receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set, followed by lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-59 years.
- Patients scheduled for oral intubation.
- Physical status ASA I and II (American Society of Anesthesiologists).
- Patients with Mallampati classification I-II.
Key exclusion criteria (6 listed)
- History of allergy to the drugs that will be used.
- Pregnant patients.
- Patients taking medications that affect blood pressure and heart rate, such as vasodilators, adrenergic blockers, antiarrhythmics, and cardiac stimulants.
- Patients with arrhythmias, AV block, liver disorders, hypertension, and hypoalbuminemia.
- Patients who have been given opioids within the last 24 hours.
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 |
|---|---|---|
| DexmedetomidinePatient in experimental arms will received intravenous dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before general anesthesia induction | Drug | Dexmedetomidine |
| LidocainPatient in experimental arms will receive intravenous lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation | Drug | Lidocaine |
Primary outcome
Systolic blood pressure
Time frame: Right after endotracheal intubation until 5 minutes after endotracheal intubation
Diastolic blood pressure
Time frame: Right after endotracheal intubation until 5 minutes after endotracheal intubation
Heart rate
Time frame: Right after endotracheal intubation until 5 minutes after endotracheal 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 27 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Lidocain in people with General Anesthesia, run by Universitas Padjadjaran at 1 site in Indonesia.
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 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: finished, as of the sponsor's last update on 27 Aug 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 Indonesia. 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?
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?
Systolic blood pressure (time frame: Right after endotracheal intubation until 5 minutes after endotracheal intubation). The study lists 3 primary outcomes in all. 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 27 Aug 2024.