DexmedetomidinePhase 2NCT06327399
Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation.
A Phase 2 study testing Dexmedetomidine infusion, Dexmedetomidine bolus and Atropine Sulfate in people with Dexmedetomidine and Intubation Complication, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Dexmedetomidine bolus dose may provide similar or less hemodynamic changes (less bradycardia and less hypertension) than infusion dose during induction of anaesthesia and tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, Intubation Complication
- What is being tested?
- Dexmedetomidine infusion, Dexmedetomidine bolus and Atropine Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 20 Sep 2024
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II patients.
- Mallampati grade I and II.
Who cannot join
- Patient refusal.
- Morbid obesity.
- Predicted difficult airway/unanticipated difficult intubation or laryngoscopic attempt lasting greater than 15 seconds or two attempts or more.
- Patients with uncontrolled sepsis.
- Pregnancy or breast feeding.
- Patients with renal impairment i.e. SCr ≥ 1.5
- Any patient on regular intake of beta blockers or calcium channel blockers.
- CNS disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose on Hemodynamic Changes During Laryngoscopy and Tracheal Intubation in Adults. A Randomized Comparative Study.
Dexmedetomidine bolus dose may provide similar or less hemodynamic changes (less bradycardia and less hypertension) than infusion dose during induction of anaesthesia and tracheal intubation.
Read the detailed description
Preoperative assessment of all patients undergoing elective surgical procedures under general anaesthesia comprises history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained. The patients will be continuously monitored in the operating room for heart rate, blood pressure, and oxygen saturation (baseline values). Then a 20-gauge cannula will be inserted.
Patients will be randomly assigned into two groups: Group A will receive Dexmedetomidine infusion dose of 1 mcg/kg diluted to 100 ml normal saline infused over 10 minutes and Group B will receive Dexmedetomidine bolus dose of 0.3 mcg/kg diluted to 10 mL normal saline administered intravenously over 60 seconds. Then Patients will be induced with propofol 2mg/kg, followed by atracurium 0.5 mg/kg IV. After 3 minutes, tracheal intubation will be performed with an appropriate size of cuffed tracheal tube and connected to end tidal CO2 monitor. After confirmation of bilateral equal air entry, it is connected to mechanical ventilation using isoflurane 1.2% for maintaining anesthesia and keeping end tidal CO2 between 35-40 mmHg, Ringer's solution at a rate 5ml/kg/hour IV will be infused for fluid maintenance. If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given. If MAP decreases below 50 mmHg, boluses of 10 mg ephedrine will be given, while escalation of MAP will be treated by boluses of 50 mg propofol.
At the end of surgery, the inhaled gas is off and the patient is reversed with neostigmine 0.05mg/kg and atropine 0.01mg/kg, then extubation is done. The two groups will be observed for changes in hemodynamic parameters i.e. heart rate (HR) and mean arterial blood pressure at preinduction period (baseline), after 1 min from dexmeditomedine taking, after induction, at intubation and 1,3,5 and 10 min after intubation. No intervention will be allowed during these 10 minutes and morphine at a dose 0.1mg/kg will be used as analgesia for surgery after 10 minutes.
- Conditions
- Dexmedetomidine, Intubation Complication
- Being tested
- Dexmedetomidine infusion, Dexmedetomidine bolus, Atropine Sulfate, Ephedrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
Also called infusion
patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min before induction.
Dexmedetomidine bolusDrug
Also called Bolus
patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.
Atropine SulfateDrug
If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.
EphedrineDrug
If mean blood pressure decreases below 50 mmHg, boluses of 10 mg ephedrine will be given
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min. Receives: Drug: Dexmedetomidine infusion; Drug: Atropine Sulfate; Drug: Ephedrine |
| Group B | Active comparator | patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds. Receives: Drug: Dexmedetomidine bolus; Drug: Atropine Sulfate; Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure upon laryngoscopy
mean blood pressure measurement (mmhg) during laryngoscopy
Measured: 1 minute
Secondary outcomes (2)
Blood pressure & Heart rate
Heart rate (bpm), Systolic, Diastolic and Mean arterial blood pressure (mmhg)
Measured: 1 min after dexmeditomedine, after induction, at intubation and 1,3,5 and 10 min after intubation
Bradycardia
Number of events : If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.
Measured: from start of dexmedetomidine injection before induction till 10 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 posted25 Mar 2024
- Study start1 Apr 2024
- Primary completion20 Aug 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maged gamal, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327399
- Sponsor's protocol ID
- MS-373-2023
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose on Hemodynamic Changes During Laryngoscopy and Tracheal Intubation in Adults. A Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT06327399
- Acronym / sponsor ID
- MS-373-2023
- Conditions
- Dexmedetomidine, Intubation Complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 25 Mar 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.
Dexmedetomidine bolus dose may provide similar or less hemodynamic changes (less bradycardia and less hypertension) than infusion dose during induction of anaesthesia and tracheal intubation.
Detailed description
Preoperative assessment of all patients undergoing elective surgical procedures under general anaesthesia comprises history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained. The patients will be continuously monitored in the operating room for heart rate, blood pressure, and oxygen saturation (baseline values). Then a 20-gauge cannula will be inserted.
Patients will be randomly assigned into two groups: Group A will receive Dexmedetomidine infusion dose of 1 mcg/kg diluted to 100 ml normal saline infused over 10 minutes and Group B will receive Dexmedetomidine bolus dose of 0.3 mcg/kg diluted to 10 mL normal saline administered intravenously over 60 seconds. Then Patients will be induced with propofol 2mg/kg, followed by atracurium 0.5 mg/kg IV. After 3 minutes, tracheal intubation will be performed with an appropriate size of cuffed tracheal tube and connected to end tidal CO2 monitor. After confirmation of bilateral equal air entry, it is connected to mechanical ventilation using isoflurane 1.2% for maintaining anesthesia and keeping end tidal CO2 between 35-40 mmHg, Ringer's solution at a rate 5ml/kg/hour IV will be infused for fluid maintenance. If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given. If MAP decreases below 50 mmHg, boluses of 10 mg ephedrine will be given, while escalation of MAP will be treated by boluses of 50 mg propofol.
At the end of surgery, the inhaled gas is off and the patient is reversed with neostigmine 0.05mg/kg and atropine 0.01mg/kg, then extubation is done. The two groups will be observed for changes in hemodynamic parameters i.e. heart rate (HR) and mean arterial blood pressure at preinduction period (baseline), after 1 min from dexmeditomedine taking, after induction, at intubation and 1,3,5 and 10 min after intubation. No intervention will be allowed during these 10 minutes and morphine at a dose 0.1mg/kg will be used as analgesia for surgery after 10 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexmedetomidine infusion, Drug: Atropine Sulfate, Drug: Ephedrinepatients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min. |
| Group B | Active comparator | Drug: Dexmedetomidine bolus, Drug: Atropine Sulfate, Drug: Ephedrinepatients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I and II patients.
- Mallampati grade I and II.
Key exclusion criteria (8 listed)
- Patient refusal.
- Morbid obesity.
- Predicted difficult airway/unanticipated difficult intubation or laryngoscopic attempt lasting greater than 15 seconds or two attempts or more.
- Patients with uncontrolled sepsis.
- Pregnancy or breast feeding.
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 |
|---|---|---|
| Dexmedetomidine infusionAlso: infusionpatients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min before induction. | Drug | Group A |
| Dexmedetomidine bolusAlso: Boluspatients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds. | Drug | Group B |
| Atropine SulfateIf heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given. | Drug | Group A, Group B |
| EphedrineIf mean blood pressure decreases below 50 mmHg, boluses of 10 mg ephedrine will be given | Drug | Group A, Group B |
Primary outcome
Mean blood pressure upon laryngoscopy
Time frame: 1 minute
mean blood pressure measurement (mmhg) during laryngoscopy
2 secondary outcomes
Blood pressure & Heart rate
Time frame: 1 min after dexmeditomedine, after induction, at intubation and 1,3,5 and 10 min after intubation
Bradycardia
Time frame: from start of dexmedetomidine injection before induction till 10 minutes after 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 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Dexmedetomidine infusion, Dexmedetomidine bolus and Atropine Sulfate in people with Dexmedetomidine and Intubation Complication, run by Kasr El Aini Hospital 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 8 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 9 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean blood pressure upon laryngoscopy (time frame: 1 minute). 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 9 Jul 2026.