Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation.

NCT ID: NCT06327399

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-21
• Study Completion Date: 2024-05-31

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.

Conditions

Dexmedetomidine; Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine infusion

Intervention Type: DRUG

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

Atropine Sulfate

Intervention Type: DRUG

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

Ephedrine

Intervention Type: DRUG

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

Propofol

Intervention Type: DRUG

Propofol 20 mg boluses till loss of contact

Group B

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine bolus

Intervention Type: DRUG

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

Atropine Sulfate

Intervention Type: DRUG

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

Ephedrine

Intervention Type: DRUG

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

Propofol

Intervention Type: DRUG

Propofol 20 mg boluses till loss of contact

Interventions

Dexmedetomidine infusion

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

Intervention Type: DRUG

Dexmedetomidine bolus

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

Intervention Type: DRUG

Atropine Sulfate

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

Intervention Type: DRUG

Ephedrine

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

Intervention Type: DRUG

Propofol

Propofol 20 mg boluses till loss of contact

Intervention Type: DRUG

Other Intervention Names

infusion; Bolus; induction of anethesia

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

maged gamal

Anesthesia lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Hospitals

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ramy m alkonaiesy, MD

Role: CONTACT

ramyalkonaiesy@gmail.com

01224883990 ext. +2

Amany H saleh, MD

Role: CONTACT

dr_amanyhassan@Hotmail.com

01224259808 ext. +2

Facility Contacts

Maher a Fawzy, MD

Role: primary

kasralainirec@kasralainy.edu.eg

01201730249

Other Identifiers

MS-373-2023

Identifier Type: -

Identifier Source: org_study_id