Hemodynamic InstabilityPhase 4NCT06103721
Role of Nebulized Dexmedetomidine in Blunting the Effects of Direct Laryngoscopy and Endotracheal Tube on Heart Rate and Blood Pressure.
A Phase 4 study testing Dexmedetomidine Injection [Precedex] and Normal Saline in people with Hemodynamic Instability, run by Muhammad Haroon Anwar at 1 site in Pakistan.
Trial summary
The goal of this interventional study is to check the effectiveness of nebulized Dexmedetomidine in preventing the rise in blood pressure and heart rate in patients undergoing General Anesthesia. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Dexmedetomidine Injection [Precedex] and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Nov 2023to Dec 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: 16 years and above.
- American Society of Anesthesiologists (ASA) class: I, II and III.
- Elective surgeries under General Endotracheal Anesthesia.
- Potentially difficult airway.
Who cannot join
- Pregnancy
- Body mass index >35 kg/m2
- Known allergy to drugs used in the study
- Liver and renal insufficiency
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences
Islamabad, Federal, 44000
Muhammad Haroon Anwar, MBBS, +92-333-5236956, haroonanwar22@gmail.com
Naheed Fatima, MBBS,FCPS, +92-300-5236655, naheedfk73@gmail.com
About this study
Official title: Preoperative Dexmedetomidine Nebulization in Blunting Hemodynamic Stress Response to Laryngoscopy
The goal of this interventional study is to check the effectiveness of nebulized Dexmedetomidine in preventing the rise in blood pressure and heart rate in patients undergoing General Anesthesia. The study will be conducted in patients presenting for elective surgery either healthy or having co-existing medical conditions which affect their daily living to a moderate extent.
These participants will require general anesthesia for their surgical procedure. General Anesthesia will make the patient unconscious, unable to breath and protect his airway.
Read more
One way to provide airway and ventilatory support to such patient is by placing endotracheal tube into the patient's windpipe and for that direct laryngoscopy is performed. Direct laryngoscopy is one of the most painful stimulus a person can receive. Therefore like any other thing that causes pain it leads to a rise in blood pressure and heart rate. This can be harmful to the person suffering from cardiac disease.
As a result one must blunt this painful response while providing adequate airway support to the patient needing General Anesthesia. There are number of drugs which can be used for this purpose. They can be given Intravenously or directly into the patient upper airway so that they can make the area numb. One of the drugs which is used for this purpose is Dexmedetomidine.
In this study Dexmedetomidine will be nebulized and directly deliver to the patient's airway just like an asthmatic receives medication from inhaler devices. After giving sufficient time for drug to work, airway will be secured with endotracheal tube using direct laryngoscopy and the degree of rise in Blood Pressure and Heart rate of the patient will be observed. The results will be compared with a control group receiving a substance which looks like a drug but has no effects.
Read the detailed description
Induction of General Anesthesia results in loss of respiratory drive and protective airway reflexes. This predisposes the person to respiratory failure and aspiration. As a result, airway has to be secured and mechanical ventilation is required. There are numerous ways to secure airway; the most popular being endotracheal tube placement by the help of laryngoscope. Laryngoscopy provides a line of sight from operator's eye to glottis of the patient so that endotracheal tube can be placed. However, laryngoscopy is one of the potent painful stimuli a person can receive. Therefore it results in a number of hemodynamic consequences such as tachycardia and hypertension. This can be problematic for a number of patients such as those with Ischemic Heart Disease, Stenotic Valvular lesions etc.
Blunting this hemodynamic stress response can lead to a number of benefits such as optimal control of hemodynamics. A number of drugs have been used for this purpose such as Lignocaine, Esmolol, Dexmedetomidine, Magnesium Sulphate etc.
Esmolol is a cardio selective beta blocker having a half life of 9 minutes. It blunts the tachycardic and hypertensive response of laryngoscopy. It is given Intravenously.
IV lignocaine given at a dose 1-1.5 mg/kg about 1.5 minutes before intubation can blunt these responses.
Similarly, Dexmedetomidine can be given intravenously to blunt hemodynamic stress response to laryngoscopy. It is an alpha 2 agonist; centrally acting sympatholytic and analgesic agent. Numerous studies and practical experience have shown it be more effective than Beta blockers and Lignocaine. However IV administration of the drug results in hypotension and bradycardia .
If Dexmedetomidine is administered via nebulizer device it can prevent laryngoscopic response as well as its side effects can be minimized.
This study will utilize nebulized Dexmedetomidine to prevent hemodynamic stress response to laryngoscopy.
- Conditions
- Hemodynamic Instability
- Being tested
- Dexmedetomidine Injection [Precedex], Normal Saline
- Keywords
- Dexmedetomidine, Stress response to laryngoscopy, General Anaesthesia, Direct Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
Also called Intervention
Dexmedetomidine will be diluted in 20 ml of Normal Saline to produce a concentration of 20 mcg/ml. Then it will be taken from the dilution at a dose of 1.0 mcg/kg and that will be added in 2-3 ml of Normal Saline to make it a final volume of 10ml. The resultant mixture will be used to nebulize the patients for 5 minutes, 15 minutes prior to induction of General Anesthesia. Then general anesthesia will be induced with 1mg of Midazolam, 2mg/kg of Propofol, 0.5 mg/kg of Atracurium. Prior to endotracheal tube placement, airway will be managed with bag mask ventilation for 3 minutes. Vitals will be measured pre-nebulization, pre-induction, at 1 minute intervals during bag mask ventilation and immediately after placement of endotracheal tube.
Normal SalineDrug
Also called Placebo
Patients in the placebo group will be nebulized with 10 ml of Normal Saline, 15 minutes prior to induction of general anesthesia. Then general anesthesia will be induced with 1mg of Midazolam, 2mg/kg of Propofol, 0.5 mg/kg of Atracurium. Prior to endotracheal tube placement, airway will be managed with bag mask ventilation for 3 minutes. Vitals will be measured pre-nebulization, pre-induction, at 1 minute intervals during bag mask ventilation and immediately after placement of endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Group Dexmedetomidine | Experimental | This will be the intervention group. Patients entering this group through computer generated random numbers will receive nebulization Dexmedetomidine in the pre-operative area under the supervision of consultant anesthetist. Receives: Drug: Dexmedetomidine Injection [Precedex] |
| Group Normal Saline | Placebo comparator | This will be the placebo or control group. Patients entering this group through computer generated random numbers will receive nebulization with Normal Saline (placebo) in the pre-operative area under the supervision of consultant anesthetist. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart Rate is measured as a part of standard ASA monitoring through electronic cardiac monitor showing electrocardiogram as well as heart rate (no. of beats/min).
Measured: Heart Rate will be assessed pre-nebulization, pre-induction, and at 1 minute intervals during bag mask ventilation, and immediately after endotracheal tube placement.
Blood Pressure
Blood pressure including Systolic, Diastolic and Mean arterial pressure is measured as a part of standard ASA monitoring. This is measured in units of mm of Hg through automated Non-invasive Blood pressure monitoring device.
Measured: Systolic, Diastolic and Mean arterial blood pressure will be assessed pre-nebulization, pre-induction, and at 1 minute intervals during bag mask ventilation, and immediately after endotracheal tube placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start21 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients fulfilling the inclusion criteria will be enrolled and divided into two groups through computer generated random numbers. Intervention will be done in the preoperative area under supervision of consultant anesthetist. Afterwards patient will be shifted to operating room, standard ASA monitoring will be attached. General anesthesia will be induced with 1mg of midazolam, 2mg/kg of propofol and 0.5 mg/kg of atracurium. Patient will then be bag mask ventilated for 3 minutes using 100% oxygen at 5 L/min along with Sevoflurane at a MAC (Minimum alveolar concentration) of 1. Vitals will be measured pre-nebulization, pre-induction, and at 1-minute intervals during bag mask ventilation and finally immediately after endotracheal tube placement. Failure to blunt hemodynamic response will be defined as rise in heart rate or blood pressure by more than 20% from pre-induction values immediately after laryngoscopy and endotracheal tube placement which will be managed accordingly.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Haroon Anwar
- Sponsor type
- Other government
- Collaborators
- Pakistan Institute of Medical Sciences
- Responsible party
- Sponsor-investigator, Muhammad Haroon Anwar, Pakistan Institute of Medical Sciences
- Investigators
- Muhammad Haroon Anwar, MBBS, Principal investigator, Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103721
- Sponsor's protocol ID
- No.F.3-1/2023(ERRB)/Chairman
- Status last verified
- Dec 2023
- First submitted
- 16 Oct 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20.
PubMed 32434291
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Dexmedetomidine Nebulization in Blunting Hemodynamic Stress Response to Laryngoscopy
- ClinicalTrials.gov ID
- NCT06103721
- Acronym / sponsor ID
- No.F.3-1/2023(ERRB)/Chairman
- Conditions
- Hemodynamic Instability
- Keywords
- Dexmedetomidine, Stress response to laryngoscopy, General Anaesthesia, Direct Laryngoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Muhammad Haroon AnwarOther government
- Collaborators
- Pakistan Institute of Medical Sciences
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Oct 2023 (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.
The goal of this interventional study is to check the effectiveness of nebulized Dexmedetomidine in preventing the rise in blood pressure and heart rate in patients undergoing General Anesthesia. The study will be conducted in patients presenting for elective surgery either healthy or having co-existing medical conditions which affect their daily living to a moderate extent.
These participants will require general anesthesia for their surgical procedure. General Anesthesia will make the patient unconscious, unable to breath and protect his airway.
One way to provide airway and ventilatory support to such patient is by placing endotracheal tube into the patient's windpipe and for that direct laryngoscopy is performed. Direct laryngoscopy is one of the most painful stimulus a person can receive. Therefore like any other thing that causes pain it leads to a rise in blood pressure and heart rate. This can be harmful to the person suffering from cardiac disease.
As a result one must blunt this painful response while providing adequate airway support to the patient needing General Anesthesia. There are number of drugs which can be used for this purpose. They can be given Intravenously or directly into the patient upper airway so that they can make the area numb. One of the drugs which is used for this purpose is Dexmedetomidine.
In this study Dexmedetomidine will be nebulized and directly deliver to the patient's airway just like an asthmatic receives medication from inhaler devices. After giving sufficient time for drug to work, airway will be secured with endotracheal tube using direct laryngoscopy and the degree of rise in Blood Pressure and Heart rate of the patient will be observed. The results will be compared with a control group receiving a substance which looks like a drug but has no effects.
Detailed description
Induction of General Anesthesia results in loss of respiratory drive and protective airway reflexes. This predisposes the person to respiratory failure and aspiration. As a result, airway has to be secured and mechanical ventilation is required. There are numerous ways to secure airway; the most popular being endotracheal tube placement by the help of laryngoscope. Laryngoscopy provides a line of sight from operator's eye to glottis of the patient so that endotracheal tube can be placed. However, laryngoscopy is one of the potent painful stimuli a person can receive. Therefore it results in a number of hemodynamic consequences such as tachycardia and hypertension. This can be problematic for a number of patients such as those with Ischemic Heart Disease, Stenotic Valvular lesions etc.
Blunting this hemodynamic stress response can lead to a number of benefits such as optimal control of hemodynamics. A number of drugs have been used for this purpose such as Lignocaine, Esmolol, Dexmedetomidine, Magnesium Sulphate etc.
Esmolol is a cardio selective beta blocker having a half life of 9 minutes. It blunts the tachycardic and hypertensive response of laryngoscopy. It is given Intravenously.
IV lignocaine given at a dose 1-1.5 mg/kg about 1.5 minutes before intubation can blunt these responses.
Similarly, Dexmedetomidine can be given intravenously to blunt hemodynamic stress response to laryngoscopy. It is an alpha 2 agonist; centrally acting sympatholytic and analgesic agent. Numerous studies and practical experience have shown it be more effective than Beta blockers and Lignocaine. However IV administration of the drug results in hypotension and bradycardia .
If Dexmedetomidine is administered via nebulizer device it can prevent laryngoscopic response as well as its side effects can be minimized.
This study will utilize nebulized Dexmedetomidine to prevent hemodynamic stress response to laryngoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients fulfilling the inclusion criteria will be enrolled and divided into two groups through computer generated random numbers. Intervention will be done in the preoperative area under supervision of consultant anesthetist. Afterwards patient will be shifted to operating room, standard ASA monitoring will be attached. General anesthesia will be induced with 1mg of midazolam, 2mg/kg of propofol and 0.5 mg/kg of atracurium. Patient will then be bag mask ventilated for 3 minutes using 100% oxygen at 5 L/min along with Sevoflurane at a MAC (Minimum alveolar concentration) of 1. Vitals will be measured pre-nebulization, pre-induction, and at 1-minute intervals during bag mask ventilation and finally immediately after endotracheal tube placement. Failure to blunt hemodynamic response will be defined as rise in heart rate or blood pressure by more than 20% from pre-induction values immediately after laryngoscopy and endotracheal tube placement which will be managed accordingly.
| Arm | Type | Receives |
|---|---|---|
| Group Dexmedetomidine | Experimental | Drug: Dexmedetomidine Injection [Precedex]This will be the intervention group. Patients entering this group through computer generated random numbers will receive nebulization Dexmedetomidine in the pre-operative area under the supervision of consultant anesthetist. |
| Group Normal Saline | Placebo comparator | Drug: Normal SalineThis will be the placebo or control group. Patients entering this group through computer generated random numbers will receive nebulization with Normal Saline (placebo) in the pre-operative area under the supervision of consultant anesthetist. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 16 years and above.
- American Society of Anesthesiologists (ASA) class: I, II and III.
- Elective surgeries under General Endotracheal Anesthesia.
- Potentially difficult airway.
Key exclusion criteria (4 listed)
- Pregnancy
- Body mass index >35 kg/m2
- Known allergy to drugs used in the study
- Liver and renal insufficiency
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 Injection [Precedex]Also: InterventionDexmedetomidine will be diluted in 20 ml of Normal Saline to produce a concentration of 20 mcg/ml. Then it will be taken from the dilution at a dose of 1.0 mcg/kg and that will be added in 2-3 ml of Normal Saline to make it a final volume of 10ml. The resultant mixture will be used to nebulize the patients for 5 minutes, 15 minutes prior to induction of General Anesthesia. Then general anesthesia will be induced with 1mg of Midazolam, 2mg/kg of Propofol, 0.5 mg/kg of Atracurium. Prior to endotracheal tube placement, airway will be managed with bag mask ventilation for 3 minutes. Vitals will be measured pre-nebulization, pre-induction, at 1 minute intervals during bag mask ventilation and immediately after placement of endotracheal tube. | Drug | Group Dexmedetomidine |
| Normal SalineAlso: PlaceboPatients in the placebo group will be nebulized with 10 ml of Normal Saline, 15 minutes prior to induction of general anesthesia. Then general anesthesia will be induced with 1mg of Midazolam, 2mg/kg of Propofol, 0.5 mg/kg of Atracurium. Prior to endotracheal tube placement, airway will be managed with bag mask ventilation for 3 minutes. Vitals will be measured pre-nebulization, pre-induction, at 1 minute intervals during bag mask ventilation and immediately after placement of endotracheal tube. | Drug | Group Normal Saline |
Primary outcome
Heart Rate
Time frame: Heart Rate will be assessed pre-nebulization, pre-induction, and at 1 minute intervals during bag mask ventilation, and immediately after endotracheal tube placement.
Heart Rate is measured as a part of standard ASA monitoring through electronic cardiac monitor showing electrocardiogram as well as heart rate (no. of beats/min).
Blood Pressure
Time frame: Systolic, Diastolic and Mean arterial blood pressure will be assessed pre-nebulization, pre-induction, and at 1 minute intervals during bag mask ventilation, and immediately after endotracheal tube placement.
Blood pressure including Systolic, Diastolic and Mean arterial pressure is measured as a part of standard ASA monitoring. This is measured in units of mm of Hg through automated Non-invasive Blood pressure monitoring device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Results publication: PubMed 32434291Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20.
- 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.
Muhammad Haroon Anwar, MBBS principal investigator
Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Injection [Precedex] and Normal Saline in people with Hemodynamic Instability, run by Muhammad Haroon Anwar at 1 site in Pakistan.
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 4 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 15 Dec 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Haroon Anwar, MBBS (+92-333-5236956, haroonanwar22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: Heart Rate will be assessed pre-nebulization, pre-induction, and at 1 minute intervals during bag mask ventilation, and immediately after endotracheal tube placement.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103721, which also lists 1 linked publication.
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 15 Dec 2023.