Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581731
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Comparison of Remifentanil with a Combination of Remimazolam and Dexmedetomidine for Awake Tracheal Intubation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Safety and Effectiveness of Remifentanil with a Combination of Remimazolam and Dexmedetomidine for Awake Fibreoptic Nasotracheal Intubation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Awake fiberoptic intubation AFOI requires airway surface anesthesia to inhibit pharyngeal reflex glottis closure reflex and cough reflex Additionally the use of sedative drugs can enhance patient comfort and tolerance reduce anxiety and eliminate harmful effects on systemic hemodynamicsThe objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation
Detailed Description:
Awake fiberoptic intubation AFOI is regarded as the gold standard for managing anticipated difficult airways due to its high success rate and low risk However awake intubation can induce significant stress responses in patients including increased heart rate severe blood pressure fluctuations and intense coughing Therefore during awake intubation airway local anesthesia techniques are necessary to suppress the gag reflex glottic closure reflex and cough reflex enabling the patient to tolerate the stress responses associated with intubation In addition to local anesthesia sedatives are typically required to enhance patient comfort and tolerance reduce anxiety and minimize adverse effects on systemic hemodynamics However excessive sedation can lead to complications such as airway collapse hypoxemia and respiratory depression while insufficient sedation may result in severe coughing and discomfort The ideal sedative state preserves spontaneous breathing maintains low sensitivity to nausea and vomiting and allows for awakening if necessary Safety and comfort are the primary considerations in selecting sedative medications therefore sedative and analgesic drugs used in AFOI should be short-acting easily titratable and minimally suppressive of spontaneous respirationThe most commonly used sedatives include benzodiazepines propofol remifentanil and dexmedetomidine During AFOI a combination of the two drugs can be used to meet the requirements of sedation and analgesia Remifentanil has a fast onset fast elimination and does not rely on liver and kidney function It is the first ultra short acting opioid drug in clinical practice and its termination of action is not significantly related to infusion time and dose It provides sufficient analgesia and good anesthesia controllability for patients with difficult airway during conscious intubation Rimazolen is an ester metabolite derivative of the benzodiazepine drug midazolam which has been successfully used for the induction and maintenance of programmed sedation and general anesthesia due to its fast onset short duration of sedative effect and short recovery time with a half-life of 5-10 minutes In addition remifentanil has no effect on heart rate electrocardiogram blood pressure and respiratory rate Rimazolen accumulates rarely after long-term infusion and does not affect liver and kidney function making it safe for patients with liver or kidney dysfunction In addition remifentanil sedation can be reversed by flumazenil and it may be a useful medication in clinical situations that require maintenance of spontaneous ventilation Research reports that the combination of benzodiazepines and opioids may be an ideal drug for AFOI Dexmedetomidine is a highly selective α 2-adrenergic agonist that produces dose-dependent sedative and anti anxiety effects with a certain degree of analgesic effect It can preserve airway reflex dilate tracheal smooth muscle and inhibit cough response without causing respiratory depression However it may cause bradycardia heart block and hypotension and has a slow onset when used alone Dexmedetomidine has a rapid onset of action and a terminal half-life of 2 hours It is metabolized in the liver and its metabolites are eliminated through urine Therefore the dosage should be reduced appropriately in patients with renal or liver dysfunction Dexmedetomidine combined with opioid drugs is also commonly used for AFOI
There is currently no consensus on the safest and most effective sedative drugs for conscious tracheal intubation and using a single drug often fails to meet all the requirements of Awake Fiberoptic Intubation AFOI The ideal sedative should provide effective conscious sedation while maintaining autonomous ventilation ensuring smooth intubation conditions and stabilizing hemodynamics Therefore the objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation
There is currently no consensus on the safest and most effective sedative drugs for conscious tracheal intubation and using a single drug often fails to meet all the requirements of Awake Fiberoptic Intubation AFOI The ideal sedative should provide effective conscious sedation while maintaining autonomous ventilation ensuring smooth intubation conditions and stabilizing hemodynamics Therefore the objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None