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CTRI Number  CTRI/2023/02/049908 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 08/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To study the effect of anxiety before the procedure on the total propofol consumed in patients during the endoscopic retrograde cholangiopancreatography(ERCP)procedure. 
Scientific Title of Study   Correlation of pre procedural anxiety on propofol consumption in patients undergoing endoscopic retrograde cholangiopancreatography(ERCP) procedure. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AYESHA SIDDIQUA 
Designation  RESIDENT IN ANAESTHESIA 
Affiliation  MS RAMAIAH MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIA, 2ND FLOOR, NEXT TO MULTIDISCIPLINARY ICU, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR, BANGALORE NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE

Bangalore
KARNATAKA
560054
India 
Phone  9591900499  
Fax    
Email  aishsid6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ARCHANA S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  MS RAMAIAH MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
Bangalore
KARNATAKA
560054
India 
Phone  9845121444  
Fax    
Email  archvinddoc@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  ARCHANA S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  MS RAMAIAH MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
Koppal
KARNATAKA
560054
India 
Phone  9845121444  
Fax    
Email  archvinddoc@yahoo.co.in  
 
Source of Monetary or Material Support  
MS RAMAIAH MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  MS RAMAIH MEDICAL COLLEGE 
Address  NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE - 560054 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ARCHANA S  MS RAMAIAH MEDICAL COLLEGE HOSPITAL  GASTROENTEROLOGY OPD
Bangalore
KARNATAKA 		 9845121444

archvinddoc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE MS RAMAIAH MEDICAL COLLEGE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Age : 18-65 years
• ASA physical status 1 and 2
• BMI: 18-30 kg/m2
• Educational background and mental status sufficient to be able to fill out the questionnaire intended for assessment.
 
 
ExclusionCriteria 
Details  1 Pregnant women
2 Patients who have contraindication to propofol administration
3 Urgent , emergent ERCP’s
4 Patients with psychiatric or neurological disorders
• Patients on psychiatric medications or alcohol consumption
• Patients with significant cardiovascular,respiratory, or liver diseases
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate pre procedural anxiety using beck anxiety inventory (BAI) prior to ERCP procedure ,and to determine the cumulative propofol consumption during the ERCP procedure.  Before procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the frequency of hypotension and desaturation during the ERCP .  During the procedure 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   01/03/2023 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aishsid6@gmail.com].

  6. For how long will this data be available start date provided 25-04-2024 and end date provided 25-04-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Anxiety is an unpleasant feeling of apprehension, irritability, and strain. An individual experiencing anxiety has a dramatic neuroendocrine response  which results in  increased cardiovascular activity and metabolism. This results in increase in catecholamine levels, sympathetic activity, and cortisol secretion .

 

Psychological factors are considered to influence patients’ anaesthetic requirements and their individual differences in postoperative pain, even in the same surgical procedures. One of these psychological factors is  preoperative anxiety which can have its effects on anaesthetic consumption, preoperative haemodynamics, neuroendocrine response, postoperative pain, and analgesic consumption 

 

Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging  diagnostic and therapeutic modality, which requires  patient’s cooperation to facilitate the interventions performed by the endoscopist, therefore adequate patient sedation is indispensable. Propofol is routinely used for sedation in ERCP due to its pharmacological properties and rapid recovery profile.

 

This study is aimed to evaluate the effects of preoperative anxiety  on  anaesthetic consumption, preoperative hemodynamics and  recovery time in patients undergoing ERCP.

 
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