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Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation.

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06327399
Enrollment
70
Registered
2024-03-25
Start date
2024-01-21
Completion date
2024-05-31
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine, Intubation Complication

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 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 till loss of verbal contact, 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.

Interventions

DRUGDexmedetomidine infusion

patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min before induction.

DRUGDexmedetomidine bolus

patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.

If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.

DRUGEphedrine

If mean blood pressure decreases below 50 mmHg, boluses of 10 mg ephedrine will be given

DRUGPropofol

Propofol 20 mg boluses till loss of contact

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean blood pressure upon laryngoscopy1 minutemean blood pressure measurement (mmhg) during laryngoscopy

Secondary

MeasureTime frameDescription
Blood pressure & Heart rate1 min after dexmeditomedine, after induction, at intubation and 1,3,5 and 10 min after intubationHeart rate (bpm), Systolic, Diastolic and Mean arterial blood pressure (mmhg)
Propfolinductiontotal boluses dose needed for induction
Bradycardiafrom start of dexmedetomidine injection before induction till 10 minutes after intubationNumber of events : If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.

Countries

Egypt

Contacts

Primary ContactRamy m alkonaiesy, MD
ramyalkonaiesy@gmail.com01224883990
Backup ContactAmany H saleh, MD
dr_amanyhassan@Hotmail.com01224259808

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026