Clinical trial

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

Name
PT (822)
Description
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.
Trial arms
Trial start
2024-02-25
Estimated PCD
2024-04-30
Trial end
2024-05-02
Status
Completed
Phase
Early phase I
Treatment
Precedex 200 MCG in 2 ML Injection
Patients received dexmedetomidine (1.5 μg/kg) as single injection over 10 minutes.
Arms:
The Dexmedetomidine Group (D)
Other names:
C group: Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).
C group:
Patients received propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg).
Arms:
The Control Group (C)
Size
74
Primary endpoint
Rate of successful intubations which was defined as both excellent and acceptable conditions.
15 minutes
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "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.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}
Updated at
2024-05-13

1 organization

1 product

3 indications

Product
Precedex
Indication
Dexmedetomidine