Effect of Dexmedetomidine on Improving Intubating Conditions Without the Use of Muscle Relaxant

Tracheal intubation is usually facilitated by the administration of anesthetic drugs including a muscle relaxant. Over the past few years, several factors have led researchers to consider omitting neuromuscular blocking agents for tracheal intubation. (1, 2) Despite the frequent use of NMBAs in clinical practice, side effects associated with NMBA use can be particularly concerning such as anaphylaxis, cardiovascular effects related to histamine release or sympathomimetic properties, Bronchospasm, and prolonged paralysis. (3) Therefore, many studies (4, 5) focused on the possibility of performing tracheal intubation without the use of neuromuscular blocking agents. The challenge was to find the correct choice and dose of induction agent, opioid, or adjuvant drug to produce adequate intubating conditions without cardiovascular side effects. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation.

Study Overview

• Status: Completed
• Conditions: Intubation; Dexmedetomidine; Muscle Relaxation
• Intervention / Treatment: Drug: Precedex 200 MCG in 2 ML Injection; Other: C group:

Detailed Description

Methods: the study is designed to be prospective randomized double blinded study. 74 ASA I, II patients will be divided into 2 groups group D and group C, 37 patients in each group. Group D will receive single dose of dexmedetomidine 1.5 mcg /kg in 50 ml normal saline over 10 min IV infusion and Group C will receive 50 ml normal saline over 10 min IV infusion. Intravenous induction of anesthesia will be done using propofol (2 mg/Kg), fentanyl (1 mcg/Kg) and atracurium (0.5 mg/Kg) in the control group versus propofol (2 mg/Kg), fentanyl (1 mg/kg) and normal saline in the dexmedetomidine group. After 2 minutes of mask ventilation with 2% sevoflurane, endotracheal intubation (ETI) with 7.5mm endotracheal tube for male patients and a 7mm endotracheal tube for female patients will be performed by an experienced anesthiolgist Base line readings including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP),) will be recorded and continuous measurements will be recorded till 5 minutes after intubation. Scoring of Intubation Conditions as follows: Intubation conditions will be evaluated using a scoring system, which includes 5 factors:

score 1 2 3 4 Laryngoscope: Easy Fair Difficult Impossible Vocal cords: Open Moving Closing Closed Coughing: None Slight Moderate Severe Jaw Relaxation: Complete Slight Stiff Rigid Limb movement: None Slight Moderate Severe

The score was interpreted into 3 categories: excellent, acceptable and poor conditions:

• Excellent conditions: received a score of 1 for all the 5 factors.
• Acceptable conditions: received a score of 2 for any of the 5 factors.
• Poor conditions received a score >2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Theodor Bilharz Research Institute
  • Cairo, Egypt, 020
    • Theodor Bilharz Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA physical status I, II.
• Age 18- 60 years old of both sexes.
• Mallampati I, II
• Patients undergoing elective surgery under general anesthesia and tracheal intubation.

Exclusion Criteria:

• Age < 18 years and ≥ 60 years
• Pregnancy
• Emergency surgery or full stomach
• Mallampati III , IV
• Renal or Hepatic patients
• Patients with any cardiac condition
• Patients with suspected difficult airway; e.g., high neck circumference, high body mass index (≥30 kg/m2), airway masses, mouth scars, neck scars, limited neck extension or history of snoring.
• Any patient on regular intake of beta blockers or calcium channel blockers
• Patients with any known hypersensitivity or contraindication to dexmedetomidine,
• Patients with significant neurological, psychiatric, or neuromuscular disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Dexmedetomidine Group (D); Patients received dexmedetomidine (1.5 μg/kg), propofol (2mg/kg), and fentanyl (1 μg/kg).	Drug: Precedex 200 MCG in 2 ML Injection; Patients received dexmedetomidine (1.5 μg/kg) as single injection over 10 minutes.; Other Names: C group: Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).
Placebo Comparator: The Control Group (C); Patients received normal saline of volume over 10 minutes.	Other: C group: Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful intubations which was defined as both excellent and acceptable conditions.	Excellent conditions: received a score of 1 for all the 5 factors.; Acceptable conditions: received a score of 2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.; Excellent conditions: received a score of 1 for all the 5 factors.; Acceptable conditions: received a score of 2 for any of the 5 factors. Both excellent and acceptable conditions was defined as successful intubations. Poor conditions was defined as failed intubations.	15 minutes

Collaborators and Investigators

• Sponsor: Theodor Bilharz Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Intubating conditions; No muscle relaxant
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypotonia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; 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; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Fentanyl; Propofol; Dexmedetomidine; Atracurium
• Other Study ID Numbers: PT (822)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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