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CTRI Number  CTRI/2024/08/072045 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 03/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of level of anxiety in patients who were priorly exposed to spinal anesthesia versus the patients who are receiving spinal anesthesia for the first time 
Scientific Title of Study   Comparison Of Preoperative Anxiety In Adult Patients Undergoing Spinal Anesthesia Electively for the Second time Or more versus the ones for the first time: An observational 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 Prajna Jayaram 
Designation  Assistant professor 
Affiliation  CDSIMER, dayanand sagar university 
Address  Department of anesthesiology, CDSIMER, Harohalli, Ramanagar dist

Bangalore Rural
KARNATAKA
562112
India 
Phone  9482614831  
Fax    
Email  prajna2594@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prajna Jayaram 
Designation  Assistant professor 
Affiliation  CDSIMER, dayanand sagar university 
Address  Department of anesthesiology, CDSIMER, Harohalli, Ramanagar dist

Bangalore Rural
KARNATAKA
562112
India 
Phone  9482614831  
Fax    
Email  prajna2594@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prajna Jayaram 
Designation  Assistant professor 
Affiliation  CDSIMER, dayanand sagar university 
Address  Department of anesthesiology, CDSIMER, Harohalli, Ramanagar dist

Bangalore Rural
KARNATAKA
562112
India 
Phone  9482614831  
Fax    
Email  prajna2594@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesia, CDSIMER hospital, Dayanand Sagar University, Harohalli, Ramanagara fist, Karnataka, India Pincode 562112 
 
Primary Sponsor  
Name  Dr Chandramma Dayanand Sagar institute of medical education and research  
Address  Dr Chandramma Dayanand Sagar institute of medical education and research, Devrakaggallahalli, Ramanagara, Karnataka Pincode 562112 
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 
Dr Prajna Jayaram  Dr Chandramma Dayanand Sagar institute of medical education and research, Ramanagara, Karnataka  4th floor, OT COMPLEX Department of anesthesiology, Dr Chandramma dayanand sagar institute of medical education and research centre, Harohalli, Ramanagar
Bangalore Rural
KARNATAKA 		 9482614831

prajna2594@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CDSIMER-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F419||Anxiety disorder, unspecified, (2) ICD-10 Condition: Z038||Encounter for observation for other suspected diseases and conditions ruled out,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients belonging to ASA PS I, ASA PS II and ASA PS III
Patients between 18 years to 75 years of age
Patients posted for elective surgery under subarachnoid blockade
Patient who will give consent
Patient who can read and write kannada or English
Patients electively posted for gynaecological cases, elective cesereans, urogenital surgery, lower abdominal surgery, lower limb surgery 
 
ExclusionCriteria 
Details  Patients with Mental Retardation, Dementia, Hearing and visual impairment
Patients posted for amputation, surgery involving massive blood loss and multiple blood transfusion
ASA 4 and above
Patient refusal 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare anxiety scores in 2 groups (group E and group NE)
E- exposed to spinal anesthesia
NE Not exposed to spinal anesthesia

Secondary outcomes postoperative pain control in 2 groups
Level of blockade achieved in 2 groups  		 Anxiety scores calculated by giving APAIS questionnaire atleast 24hrs prior to the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Level of blockade achieved in 2 groups
Level of postoperative pain control in 2 groups  		 Assessed postoperative within first 2hours 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   20/08/2024 
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="15" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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 - NO
Brief Summary    All patients who are admitted in our hospital and who fulfill the inclusion criteria will be enrolled for the study. As a part of pre-anesthetic evaluation, all the patients will be visited by the anesthesiologist in their respective ward or in the pre-anesthesia clinic, at least a day before the surgery as per institutional protocol. The process and steps involved in the administration of subarachnoid blockade and surgery will be explained in their comprehensible language for all the patients. A special emphasis will be laid on obtaining the history of previous surgery, anesthesia, no. of days of ICU stay, discharge from recovery room, backache and other pain related to surgery, history of sleep disturbances. Before collection of data all the participants will be explained about the purpose and importance of conducting the study and after receiving the informed consent, the APAIS questionnaire will be handed over to them in a language preferred by the patient. All the participants will be assured regarding maintenance of confidentiality with respect to their Identity. Data collection will be done by the anesthesiologist, a day prior to the surgery in person using Amsterdam Preoperative Anxiety Informaton Scale (APAIS) questionnaire will be issued and scores noted in both groups. All the patients who are admitted in our hospital and who fulfill the inclusion criteria will be enrolled for the study. As a part of pre-anesthetic evaluation, all the patients will be visited by the anesthesiologist in their respective ward or in the pre-anesthesia clinic, at least a day before the surgery as per institutional protocol. The process and steps involved in the administration of subarachnoid blockade and surgery will be explained in their comprehensible language for all the patients. A special emphasis will be laid on obtaining the history of previous surgery, anesthesia, no. of days of ICU stay, discharge from recovery room, backache and other pain related to surgery, history of sleep disturbances. Before collection of data all the participants will be explained about the purpose and importance of conducting the study and after receiving the informed consent, the APAIS questionnaire will be handed over to them in a language preferred by the patient. All the participants will be assured regarding maintenance of confidentiality with respect to their Identity. Data collection will be done by the anesthesiologist, a day prior to the surgery in person using Amsterdam Preoperative Anxiety Informaton Scale (APAIS) questionnaire (annexure 1). The questionnaire comprises of 6 questions, out of which first 2 questions gauge the anesthesia related anxiety, questions 5 and 6 gauge the surgery related anxiety, question 1,2,4 and 5 gauge the combined anxiety with surgery and anesthesia and lastly questions 3 and 6 throws light on the area of patient’s desire to know more about the procedure. Each of these questions will be given a response on a likert scale from score 1 to 5, which is described as "not at all" to " extremely" respectively. Any patient who has a score of over 11 will be prescribed tab Alprazolam 0.25mg on the night before surgery. On the day of surgery, as per hospital protocol, peripheral intravenous cannula will be secured and intravenous crystalloid infusion will be initiated. Following the premedication with proton pump inhibitor and antiemetic, patient will be wheeled in to the operation theatre. ASA standard monitoring will be done after positioning the patient supine on the operating table. The baseline clinical parameters viz., heart rate, blood pressure, respiratory rate and oxygen saturation will be recorded and documented in the clinical proforma. Under strict asepsis, in the sitting position, lumbar puncture will be performed with a 25 gauge Quincke Bob needle, following local infiltration of L3-L4 or L4-L5 intervertebral space with 2 ml of 2% lignocaine . After confirming the free flow of CSF, 12mg-15mg of 0.5% H- bupivacaine will be injected intrathecally. In less than 30 seconds, patient will be made to lie supine and will be tested for motor blockade and level of sensory blockade by standard clinical tests. Simultaneously the vital parameters will be recorded every 5 minutes in all patients.All the patients who are admitted in our hospital and who fulfill the inclusion criteria will be enrolled for the study. As a part of pre-anesthetic evaluation, all the patients will be visited by the anesthesiologist in their respective ward or in the pre-anesthesia clinic, at least a day before the surgery as per institutional protocol. The process and steps involved in the administration of subarachnoid blockade and surgery will be explained in their comprehensible language for all the patients. A special emphasis will be laid on obtaining the history of previous surgery, anesthesia, no. of days of ICU stay, discharge from recovery room, backache and other pain related to surgery, history of sleep disturbances. Before collection of data all the participants will be explained about the purpose and importance of conducting the study and after receiving the informed consent, the APAIS questionnaire will be handed over to them in a language preferred by the patient. All the participants will be assured regarding maintenance of confidentiality with respect to their Identity. Data collection will be done by the anesthesiologist, a day prior to the surgery in person using Amsterdam Preoperative Anxiety Informaton Scale (APAIS) questionnaire (annexure 1). The questionnaire comprises of 6 questions, out of which first 2 questions gauge the anesthesia related anxiety, questions 5 and 6 gauge the surgery related anxiety, question 1,2,4 and 5 gauge the combined anxiety with surgery and anesthesia and lastly questions 3 and 6 throws light on the area of patient’s desire to know more about the procedure. Each of these questions will be given a response on a likert scale from score 1 to 5, which is described as "not at all" to " extremely" respectively. Any patient who has a score of over 11 will be prescribed tab Alprazolam 0.25mg on the night before surgery. On the day of surgery, as per hospital protocol, peripheral intravenous cannula will be secured and intravenous crystalloid infusion will be initiated. Following the premedication with proton pump inhibitor and antiemetic, patient will be wheeled in to the operation theatre. ASA standard monitoring will be done after positioning the patient supine on the operating table. The baseline clinical parameters viz., heart rate, blood pressure, respiratory rate and oxygen saturation will be recorded and documented in the clinical proforma. Under strict asepsis, in the sitting position, lumbar puncture will be performed with a 25 gauge Quincke Bob needle, following local infiltration of L3-L4 or L4-L5 intervertebral space with 2 ml of 2% lignocaine . After confirming the free flow of CSF, 12mg-15mg of 0.5% H- bupivacaine will be injected intrathecally. In less than 30 seconds, patient will be made to lie supine and will be tested for motor blockade and level of sensory blockade by standard clinical tests. Simultaneously the vital parameters will be recorded every 5 minutes in all patients. 
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