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

NCT06409377 | Completed Phase 4 DMC

• 1 other identifier: PT (822)
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Intubation; Muscle Relaxation; Dexmedetomidine

Keywords

Dexmedetomidine; Intubating conditions; No muscle relaxant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The Dexmedetomidine Group (D)

EXPERIMENTAL

Patients received dexmedetomidine (1.5 μg/kg), propofol (2mg/kg), and fentanyl (1 μg/kg).

Drug: Precedex 200 MCG in 2 ML Injection

The Control Group (C)

PLACEBO COMPARATOR

Patients received normal saline of volume over 10 minutes.

Other: C group:

Interventions

Precedex 200 MCG in 2 ML Injection DRUG

Patients received dexmedetomidine (1.5 μg/kg) as single injection over 10 minutes.

Also known as: C group: Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).

The Dexmedetomidine Group (D)

C group: OTHER

Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).

The Control Group (C)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (2)

Theodor Bilharz research institute

Cairo, 020, Egypt

Location

Theodor Bilharz research institute

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Injections; Fentanyl; Atracurium

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Piperidines; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 74 Adults were enrolled in the study and randomized using computer generated random numbers and divided into two groups. For the purpose of double blinding, two investigators participated in this study; an anesthesiologist who was not participating in the study prepared the study drug infusions and was responsible for drug administration. Another anesthesiologist who was unaware of group's allocation was responsible for the intubation and data collection.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Patients was allocated according to the randomly generated numbers into 2 groups; 37 patients in each group. The Dexmedetomidine Group (D): Patients received dexmedetomidine (1.5 μg/kg), propofol (2mg/kg), and fentanyl (1 μg/kg). The Control Group (C): Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: February 25, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 2, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)