跳至主要内容
临床试验/CTRI/2023/03/050388
CTRI/2023/03/050388尚未招募不适用

A prospective cohort study correlating the perioperative anxiety and depression in oncosurgical patients with the dose of sedation required for awake fibreoptic intubation

Lokmanya Tilak Municipal Medical College1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年8月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
试验地点
1
主要终点
The dosage of sedation required in oncosurgical patients undergoing AFOI depends upon their pre-operative anxiety and pre-existing depression

研究概览

简要总结

Airway obstruction and consequent “cannot intubate cannot ventilate†situation is anticipated in patients with head, face and neck cancers. This may result in hypoxia and consequent serious complications. Awake fiberoptic intubation (AFOI) is one of the principal techniques recommended by the American Society of Anesthesiologists (ASA) guidelines to manage difficult airway1. The intubating fibreoptic bronchoscope (FOB) was first described in 1967 by Peter Murphy2 and has a quoted success rate of 88%–100%3. Some authors still consider it to be the gold standard in anticipated difficult airway management4. However, awake fiberoptic intubation requires calm and cooperative patients for its success. Controlled sedation and analgesia are essential as deep sedation can cause respiratory depression, while shallow anaesthesia may result in a rough cough and extreme discomfort. An ideal agent is one that can efficiently sedate the patient without compromising the patency of the airway. The ideal level of sedation is where the patient appears asleep but gives purposeful responses to verbal commands either at conversation level or at slightly louder than conversation level, maintains spontaneous breathing, without nausea and vomiting.

Several sedative agents have been successfully used for conscious sedation during AFOI such as dexmedetomidine5, fentanyl6, remifentanil7, propofol8, ketamine9, and benzodiazepines10.

Preoperative anxiety is described as an unpleasant state of uneasiness or tension that is secondary to a patient being concerned about a disease, hospitalization, anaesthesia and surgery, or the unknown11. The reported incidence of preoperative anxiety in adults ranges from 11% to 80%, depending upon the assessment method. Though improvement of diagnostic and treatment modalities have resulted in prolongation of lives of cancer patients, longer duration of hospital stays and chemotherapy can result in increased depression and feeling of helplessness amongst them. The anxiety of major surgery and awake intubation, can cause further detrimental effects on their psyche and post operative conditions. State anxiety is defined as the subjective feelings of nervousness, apprehension and tension when one is subjected to an anxiety provoking stimulus. Trait anxiety of an individual implies differences between people in the disposition to respond to stressful situations with varying amounts of state anxiety12.  Anxiety and depression can be measured using validated scores like Modified Hospital Anxiety and Depression Scale. MHADS13 , Amsterdam Preoperative Anxiety and Information Scale APAIS14and Patient health questionnaire -9 PHQ-915.

MHADS is a seven-item score, developed by Zigmond and Snaith16 that assesses “trait anxiety†and rates the responses using a four-point Likert scale (Appendix 4). On the other hand, APAIS, a score developed by Moerman N. et al17, is a screening instrument for determining the “state anxiety†of a patient18 and his or her need for information about the anaesthesia and surgical procedure (Appendix 7). Lastly, the PHQ-9 is used as a diagnostic tool to assess severe depression in primary care19 set up and has been widely used to assess depression in cancer patients20 (Appendix 1).

Though it has been clinically established that the amount of sedation and analgesia required varies from patient to patient, there is not sufficient data correlating it with the patients’ perioperative anxiety and pre-existing depression in oncosurgical patients.

The present prospective cohort study aims to correlate the dose of sedation and analgesia required for awake fibreoptic intubation with perioperative anxiety and depression in oncosurgical patients with anticipated difficult airway using three easy to administer scales viz. Modified Hospital Anxiety and Depression Scale. (MHADS), Amsterdam Preoperative Anxiety and Information Scale. (APAIS) and Patient health questionnaire -9 (PHQ-9)

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Oncosurgical patients with planned awake intubation.

排除标准

  • Patients with pre-existing psychiatric illness or on psychotropic medication.
  • Patients not willing to particiapte in study.
  • Pateints unable to understand Hindi, English , Marathi.

结局指标

主要结局

The dosage of sedation required in oncosurgical patients undergoing AFOI depends upon their pre-operative anxiety and pre-existing depression

时间窗: The sedation dose will be calculated immediately post induction ( 30 mins-1 hour)

次要结局

  • To calculate perioperative anxiety and depression using 3 scales namely- APAIS, MHADS and PHQ-9(The scores will be administered at these time intervals)

研究者

申办方类型
Government medical college

研究点 (1)

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