Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409377
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-05-07
Brief Title:
Effect of Dexmedetomidine on Improving Intubating Conditions Without the Use of Muscle Relaxant
Sponsor:
Theodor Bilharz Research Institute
Organization:
Theodor Bilharz Research Institute
Study Overview
Official Title:
Effect of Dexmedetomidine on Improving Intubating Conditions Without the Use of Muscle Relaxant
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 15 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 mgKg fentanyl 1 mcgKg and atracurium 05 mgKg in the control group versus propofol 2 mgKg fentanyl 1 mgkg and normal saline in the dexmedetomidine group After 2 minutes of mask ventilation with 2 sevoflurane endotracheal intubation ETI with 75mm 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None