| CTRI Number |
CTRI/2023/03/050388 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
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A study correlating the perioperative anxiety and depression in cancer patients with the dose of sedation required for introducing a breathing tube via a flexible scope |
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Scientific Title of Study
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A prospective cohort study correlating the perioperative anxiety and depression in oncosurgical patients with the dose of sedation required for awake fibreoptic intubation |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini Poddar |
| Designation |
Resident Doctor, Department of Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal Medical College and Hospital |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and Government Hospital, Sion
Mumbai MAHARASHTRA 400022 India |
| Phone |
09167082751 |
| Fax |
|
| Email |
nandinipoddar176@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aparna Nerurkar |
| Designation |
Additional Professor, Department of Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal Medical College |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and Government Hospital, Sion
Mumbai MAHARASHTRA 400022 India |
| Phone |
09833944243 |
| Fax |
|
| Email |
draparnanerurkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aparna Nerurkar |
| Designation |
Additional Professor, Department of Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal Medical College |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and Government Hospital, Sion
Mumbai MAHARASHTRA 400022 India |
| Phone |
09833944243 |
| Fax |
|
| Email |
draparnanerurkar@gmail.com |
|
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Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra, India -400022 |
|
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Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal Medical College |
| Address |
Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra, India -400022 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nandini Poddar |
Lokmanya tilak municipal medical college and hospital |
ENT OT, 3rd floor , Ward Building, Lokmanya Tilak Municipal Medical College and Hospital, Mumbai Mumbai (Suburban) MAHARASHTRA |
09167082751
nandinipoddar176@gmail.com |
| Nandini Poddar |
Lokmanya tilak municipal medical college and hospital |
General Surgery OT, Ward building, 3rd floor, Lokmanya Tilak Municipal Medical College and General Hospital, Sion Mumbai MAHARASHTRA |
09167082751
nandinipoddar176@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
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Intervention / Comparator Agent
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Oncosurgical patients with planned awake intubation |
|
| ExclusionCriteria |
| Details |
1) Patients with pre-existing psychiatric illness or on psychotropic medication.
2) Patients not willing to particiapte in study.
3) Pateints unable to understand Hindi, English , Marathi |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| The dosage of sedation required in oncosurgical patients undergoing AFOI depends upon their pre-operative anxiety and pre-existing depression |
The sedation dose will be calculated immediately post induction ( 30 mins-1 hour) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate perioperative anxiety and depression using 3 scales namely- APAIS, MHADS and PHQ-9 |
The scores will be administered at these time intervals
PHQ-9 and MHADS- one day before
APAIS - Pre-operatively( 1 hour before surgery)
|
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Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
08/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
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) |