Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327399
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-17
Brief Title:
Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
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:
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 mcgkg diluted to 100 ml normal saline infused over 10 minutes and Group B will receive Dexmedetomidine bolus dose of 03 mcgkg diluted to 10 mL normal saline administered intravenously over 60 seconds Then Patients will be induced with propofol till loss of verbal contact followed by atracurium 05 mgkg 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 12 for maintaining anesthesia and keeping end tidal CO2 between 35-40 mmHg Ringers solution at a rate 5mlkghour 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 005mgkg and atropine 001mgkg then extubation is done The two groups will be observed for changes in hemodynamic parameters ie heart rate HR and mean arterial blood pressure at preinduction period baseline after 1 min from dexmeditomedine taking after induction at intubation and 135 and 10 min after intubation No intervention will be allowed during these 10 minutes and morphine at a dose 01mgkg will be used as analgesia for surgery after 10 minutes
Patients will be randomly assigned into two groups Group A will receive Dexmedetomidine infusion dose of 1 mcgkg diluted to 100 ml normal saline infused over 10 minutes and Group B will receive Dexmedetomidine bolus dose of 03 mcgkg diluted to 10 mL normal saline administered intravenously over 60 seconds Then Patients will be induced with propofol till loss of verbal contact followed by atracurium 05 mgkg 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 12 for maintaining anesthesia and keeping end tidal CO2 between 35-40 mmHg Ringers solution at a rate 5mlkghour 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 005mgkg and atropine 001mgkg then extubation is done The two groups will be observed for changes in hemodynamic parameters ie heart rate HR and mean arterial blood pressure at preinduction period baseline after 1 min from dexmeditomedine taking after induction at intubation and 135 and 10 min after intubation No intervention will be allowed during these 10 minutes and morphine at a dose 01mgkg will be used as analgesia for surgery after 10 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None