Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation.

NCT06327399 | Completed Phase 2

• 1 other identifier: MS-373-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Mean blood pressure upon laryngoscopy

  mean blood pressure measurement (mmhg) during laryngoscopy

  1 minute

Secondary Outcomes (2)

• Blood pressure & Heart rate

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

• Bradycardia

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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine infusion; Drug: Atropine Sulfate; Drug: Ephedrine

Group B

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine bolus; Drug: Atropine Sulfate; Drug: Ephedrine

Interventions

Dexmedetomidine infusion DRUG

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

Also known as: infusion

Group A

Dexmedetomidine bolus DRUG

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

Also known as: Bolus

Group B

Atropine Sulfate DRUG

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

Group A; Group B

Ephedrine DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I and II patients.
• Mallampati grade I and II.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University Hospitals

Giza, Giza Governorate, 11562, Egypt

Location

MeSH Terms

Interventions

NOP-bolus regimen; Atropine; Ephedrine

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia lecturer

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion: August 20, 2024
• Study Completion: September 20, 2024
• Last Updated: July 9, 2026

Record last verified: 2024-03

Locations

EG (1)