Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103721
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-10-16
Brief Title:
Role of Nebulized Dexmedetomidine in Blunting the Effects of Direct Laryngoscopy and Endotracheal Tube on Heart Rate and Blood Pressure
Sponsor:
Muhammad Haroon Anwar
Organization:
Pakistan Institute of Medical Sciences
Study Overview
Official Title:
Preoperative Dexmedetomidine Nebulization in Blunting Hemodynamic Stress Response to Laryngoscopy
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 patients 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 patients 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
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 patients 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 patients 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 operators 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 1-15 mgkg about 15 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
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 1-15 mgkg about 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None