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CTRI Number  CTRI/2024/10/075692 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Education about anesthesia before surgery and its effect on recovery after surgery 
Scientific Title of Study   Evaluate the effect of preoperative educational counselling about perioperative care and anaesthesia technique and its impact on postoperative cognitive function in patients undergoing elective spine surgery for the first time under general anaesthesia: A Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Main operation theater complex first floor Department of Anaesthesia MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN
123 Vaishali avenue Jhanwar road Jodhpur Jodhpur RAJASTHAN 342008
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pragati Agrawal 
Designation  Junior Resident 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Main operation theater complex first floor Department of Anaesthesia MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN
Main OT Department of Anaesthesia First Floor MDM hospital Dr S N medical collage Jodhpur Rajasthan 342001 Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342001
India 
Phone  7073914491  
Fax    
Email  pragatiagrawal96@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Main operation theater complex first floor Department of Anaesthesia MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN
123 Vaishali avenue Jhanwar road Jodhpur Jodhpur RAJASTHAN 342008
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Source of Monetary or Material Support  
MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN 342001 India  
 
Primary Sponsor  
Name  MDM Hospital Dr S N Medical Collage Jodhpur RAJASTHAN 
Address  Main operation theater First floor MDM Hospital Dr S N Medical College Shastri Nagar Jodhpur Rajasthan 342001 
Type of Sponsor  Government 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 
Dr Geeta Singariya  MDM HOSPITAL  Main OT Complex First floor Department of anesthesia, MDM Hospital, Jodhpur M D M Hospital Dr S N Medical College Shastri Nagar Jodhpur RAJASTHAN 342001
Jodhpur
RAJASTHAN 		 9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group BC (Basic Counselling)  Basic Counselling about anesthetic procedure will be given to patients posted for spine surgery 
Intervention  Group: EC (Educational Counselling)  Educational Counselling about detailed anesthetic procedure and about surgery will be given to the patients posted for spine surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patient aged 18–60 years of either gender, ASA grade 1 & 2, have adequate language skills for the counselling and can provide informed consent in patients undergoing first-time elective spine surgery under general anaesthesia will be included in this study 
 
ExclusionCriteria 
Details  1. The patient is not willing to participate in this study.
2. Patients undergoing major surgeries require post-operative intensive care.
3. Patients with cognitive impairments.
4. history of other comorbidities, such as cardiac, lung, liver, or kidney disease.
5. Patients on Anti-anxiety Medication.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Early postoperative cognitive dysfunction by using Mini-Mental State Examination in patients undergoing elective spine surgery for the first time under general anesthesia.  60 minutes after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To reveal the causes of the patient’s anxieties
Emergence time [from discontinuation of anaesthetics to eye opening on command in minutes]
Extubation time [from discontinuation of anaesthetics to tracheal extubation in minutes]
Patient satisfaction score
 		 up to 24 Hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   29/10/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  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 [geetamanojkamal@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
    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  

a)  The present study will be conducted in the Department of Anaesthesiology & Critical Care, Dr. S. N. Medical College, Jodhpur (Rajasthan), after obtaining institutional ethical committee approval and written informed consent from all the patients undergoing elective spine surgery.

 
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