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临床试验/CTRI/2025/04/083935
CTRI/2025/04/083935招募中4 期

Nebulized Dexmedetomidine and Intravenous Ketamine Versus Nebulized Ketamine and Intravenous Dexmedetomidine to facilitate Awake Fiberoptic Nasotracheal Intubation in adult patients undergoing Oromaxillofacial surgeries - A randomized double blind study

Dr S R A N Bhushanam Padala1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
84
试验地点
1
主要终点
To compare the ease of intubation with the help of intubation score between the groups

研究概览

简要总结

Awake fiberoptic nasotracheal intubation is a preferred method for managing patients with anticipated difficult airways. The success of this procedure largely depends on the sedative and analgesic regimen, which must ensure the patient remains comfortable and cooperative while maintaining airway safety and reflex suppression during the procedure.Commonly used sedatives in AFOI include benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine.

Previously combination of drugs have been used for AFOI to counteract each others adverse effects. Dexmedetomidine, an  alpha 2 adrenoreceptor agonist, is an ideal choice for AFOI because it provides sedation, analgesia, and anxiolysis without significantly impairing respiratory function, which is essential for maintaining spontaneous breathing during the procedure. Additionally, dexmedetomidine can reduce salivation, which helps counteract the excessive salivation caused by ketamine during sedation.

A key advantage of dexmedetomidine is that it allows patients to remain easily arousable without agitation, unlike sedatives like propofol that may cause deeper sedation and respiratory suppression. This makes dexmedetomidine especially useful, as patients can be more easily engaged during the procedure without irritation. The relative sympatholysis achieved during dexmedetomidine infusions is an additional benefit in a procedure that may lead to elevations of heart rate and blood pressure. Nebulisation with dexmedetomidine compared to intravenous results in desirable degree of sedation and better tolerance of the procedure with adequate attenuation of the haemodynamic responses to intubation.

Ketamine, an NMDA receptor antagonist, provides both sedation and pain relief while stabilizing hemodynamics through its sympathomimetic effects, such as increasing heart rate and blood pressure. However, ketamine can also increase airway secretions, which can complicate the intubation process by making it harder to visualize the airway and increasing the risk of aspiration. Managing this side effect is crucial for a successful procedure.

Using ketamine and dexmedetomidine together offers a synergistic approach that addresses the limitations of each drug. While ketamine offers effective analgesia and sedation with sympathomimetic effects, dexmedetomidine helps control the increased secretions caused by ketamine and prevents the rise in heart rate and blood pressure that ketamine can induce. This combination leads to more stable hemodynamics, deeper sedation, and an easier intubation process.

In summary, combining ketamine and dexmedetomidine during awake fiber-optic intubation offers a balanced and effective approach to sedation and analgesia and we aim to compare different route combinations between them.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Individuals aged between 18 and 65 years scheduled for elective Oromaxillofacial surgery.
  • 2.Patients classified as American society of Anesthesiologists(ASA) physical status 1 and 2 3.Patients with predicted difficult airway (defined as mouth opening less than 2.5 cm, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, or modified Mallampati class III/IV) who are candidates for AFNI.

排除标准

  • 1.Patients who refuse or uncooperative such as those with mental retardation, lack of communication, blindness, and deafness were excluded from the study.
  • 2.Patients who had coagulation disorders, respiratory or pulmonary disorders, pregnancy or full stomach, increased intracranial pressure or intraocular pressure, and emergency surgeries or allergy to the study drugs or with risk for regurgitation–aspiration were excluded from the study.

结局指标

主要结局

To compare the ease of intubation with the help of intubation score between the groups

时间窗: During intubation

次要结局

  • To determine the difference in time taken to intubate the patients during Awake Fiberoptic Intubation in both the groups(During intubation)
  • To assess the hemodynamic variables (Heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) in both the groups(T1 – Baseline (before starting nebulization))
  • To assess the Post-operative Patient satisfaction score, Recall of procedure(During postoperative period)

研究者

发起方
Dr S R A N Bhushanam Padala
申办方类型
Other [self]

研究点 (1)

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