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Completed

NCT Number: NCT06327399

Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation.

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University Hospitals

Giza, Giza Governorate, 11562, Egypt

About this study

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 2mg/kg, 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine infusion

Drug

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

Other names: infusion

Dexmedetomidine bolus

Drug

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

Other names: Bolus

Atropine Sulfate

Drug

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

Ephedrine

Drug

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

Primary outcomes

  1. Mean blood pressure upon laryngoscopy

    Time frame: 1 minute

    mean blood pressure measurement (mmhg) during laryngoscopy

Secondary outcomes

  1. Blood pressure & Heart rate

    Time frame: 1 min after dexmeditomedine, after induction, at intubation and 1,3,5 and 10 min after intubation

    Heart rate (bpm), Systolic, Diastolic and Mean arterial blood pressure (mmhg)

  2. Bradycardia

    Time frame: from start of dexmedetomidine injection before induction till 10 minutes after intubation

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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