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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Intubation Complication
• Intervention / Treatment: Drug: Dexmedetomidine infusion; Drug: Atropine Sulfate; Drug: Ephedrine; Drug: Propofol; Drug: Dexmedetomidine bolus

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ramy m alkonaiesy, MD; Phone Number: +2 01224883990; Email: ramyalkonaiesy@gmail.com
• Study Contact Backup: Name: Amany H saleh, MD; Phone Number: +2 01224259808; Email: dr_amanyhassan@Hotmail.com

Study Locations

• Egypt
  • Giza, Egypt, 11562
    • Recruiting
    • Cairo University Hospitals
    • Contact: Maher a Fawzy, MD; Phone Number: 01201730249; Email: kasralainirec@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min.	Drug: Dexmedetomidine infusion; patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min before induction.; Other Names: infusion; Drug: Atropine Sulfate; If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.; Drug: Ephedrine; If mean blood pressure decreases below 50 mmHg, boluses of 10 mg ephedrine will be given; Drug: Propofol; Propofol 20 mg boluses till loss of contact; Other Names: induction of anethesia
Active Comparator: Group B; patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.	Drug: Atropine Sulfate; If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.; Drug: Ephedrine; If mean blood pressure decreases below 50 mmHg, boluses of 10 mg ephedrine will be given; Drug: Propofol; Propofol 20 mg boluses till loss of contact; Other Names: induction of anethesia; Drug: Dexmedetomidine bolus; patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.; Other Names: Bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean blood pressure upon laryngoscopy	mean blood pressure measurement (mmhg) during laryngoscopy	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure & Heart rate	Heart rate (bpm), Systolic, Diastolic and Mean arterial blood pressure (mmhg)	1 min after dexmeditomedine, after induction, at intubation and 1,3,5 and 10 min after intubation
Propfol	total boluses dose needed for induction	induction
Bradycardia	Number of events : If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given.	from start of dexmedetomidine injection before induction till 10 minutes after intubation

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Propofol; Dexmedetomidine; Atropine; Ephedrine
• Other Study ID Numbers: MS-373-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No