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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 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   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 
Scientific Title of Study   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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra, India -400022 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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) 
 
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)
 
 
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" 
Phase of Trial   N/A 
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. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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)

 
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