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CTRI Number  CTRI/2023/05/053265 [Registered on: 30/05/2023] Trial Registered Prospectively
Last Modified On: 26/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Understanding satisfaction regarding anaesthesia in patients undergoing laparoscopic surgery. 
Scientific Title of Study   Evaluation of patient satisfaction during perioperative anaesthetic care in adult patients undergoing elective laparoscopic surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akanksha Yadav 
Designation  Post Graduate Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029

South
DELHI
110029
India 
Phone  8319889902   
Fax    
Email  akankshay1306@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Suniti Kale 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029

South
DELHI
110029
India 
Phone  9810287852  
Fax    
Email  findsuniti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhavya Krishna 
Designation  Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029

South
DELHI
110029
India 
Phone  9810418302  
Fax    
Email  drkrishnabhavya@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Vardhman Mahavir and Safdarjung Hospital, New Delhi 
 
Primary Sponsor  
Name  Akanksha Yadav 
Address  Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029 
Type of Sponsor  Other [SELF] 
 
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 
Akanksha Yadav  Vardhman Mahavir Medical College And Safdarjung Hospital  Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029
South
DELHI 		 8319889902

akankshay1306@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: N20-N23||Urolithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age 18-65 years undergoing elective laparoscopic surgery, fulfilling the criteria of ASA Physical Status I or II. 
 
ExclusionCriteria 
Details  1) Inability to understand English or Hindi.
2) Cognitive impairment.
3) Patient on psychiatric medication and/or with a psychiatric illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate overall patient satisfaction score during perioperative anaesthetic care in adult patients undergoing elective laparoscopic surgery using a validated questionnaire.  15 minutes before surgery and 24 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate incidence of anxiety in adult patients during perioperative anaesthetic care undergoing elective laparoscopic surgery.
2) To analyze the factors determining patient satisfaction during perioperative anaesthetic care in adult patients undergoing elective laparoscopic surgery. 		 15 minutes before surgery and 24 hours after surgery. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/06/2023 
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   THIS STUDY IS A PROSPECTIVE, OBSERVATIONAL COHORT STUDY WITH AN AIM TO EVALUATE PATIENT SATISFACTION DURING PERIOPERATIVE ANAESTHETIC CARE IN ADULT PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY. THIS STUDY WILL BE DONE IN A SINGLE CENTRE IN INDIA. THE PRIMARY OUTCOME MEASURE WILL BE TO EVALUATE OVERALL PATIENT SATISFACTION SCORE DURING PERIOPERATIVE ANAESTHETIC CARE IN ADULT PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY USING A VALIDATED QUESTIONNAIRE. THE SECONDARY OUTCOMES WILL BE TO EVALUATE INCIDENCE OF ANXIETY IN ADULT PATIENTS DURING PERIOPERATIVE ANAESTHETIC CARE UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY AND TO ANALYZE THE FACTORS DETERMINING PATIENT SATISFACTION DURING PERIOPERATIVE ANAESTHETIC CARE IN ADULT PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY. RESPONSES FROM PARTICIPANTS WILL BE RECORDED PREOPERATIVELY 15 MINUTES BEFORE SURGERY AND POSTOPERATIVELY 24 HOURS AFTER THE SURGERY USING A VALIDATED, SELF DEVELOPED QUESTIONNAIRE. 
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