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Clinical trial

Effect of Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose on Hemodynamic Changes During Laryngoscopy and Tracheal Intubation in Adults. A Randomized Comparative Study.

ID
Name
MS-373-2023
Description
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.
Trial arms
Trial start
2024-01-21
Estimated PCD
2024-04-01
Trial end
2024-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Dexmedetomidine infusion
patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min before induction.
Arms:
Group A
Other names:
infusion
Dexmedetomidine bolus
patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.
Arms:
Group B
Other names:
Bolus
Atropine Sulfate
If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.
Arms:
Group A, Group B
Ephedrine
If mean blood pressure decreases below 50 mmHg, boluses of 10 mg ephedrine will be given
Arms:
Group A, Group B
Propofol
Propofol 20 mg boluses till loss of contact
Arms:
Group A, Group B
Other names:
induction of anethesia
Size
70
Primary endpoint
Mean blood pressure upon laryngoscopy
1 minute
Eligibility criteria
Inclusion Criteria: * ASA I and II patients. * Mallampati grade I and II. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2024-03-25

1 organization

4 products

2 indications

Organization
Kasr El Aini Hospital
Product
Dexmedetomidine
Indication
Dexmedetomidine
Indication
Complications of Intubation
Product
Atropine
Product
Ephedrine
Product
Propofol