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CTRI Number  CTRI/2024/04/066397 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate optimal sitting time duration after administering saddle block for better haemodynamics and safer block characteristics. 
Scientific Title of Study   A Prospective,randomized,interventional study to compare the effect of duration of sitting posture in saddle block characteristics and haemodynamic changes with 0.5% bupivacaine(hyperbaric) in patients undergoing perineal surgeries  
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 Manoj Soni 
Designation  Associate Professor 
Affiliation  SMS Medical College and attached Hospitals, Jaipur 
Address  Department of Anesthesiology,SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan

Jaipur
RAJASTHAN
332004
India 
Phone  9829472797  
Fax    
Email  manoj_sithal@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Soni 
Designation  Associate Professor 
Affiliation  SMS Medical College and attached Hospitals, Jaipur 
Address  Department of Anesthesiology,SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan


RAJASTHAN
332004
India 
Phone  9829472797  
Fax    
Email  manoj_sithal@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Divya Ghoushlia 
Designation  Junior Resident 
Affiliation  Department of Anesthesiology, SMS Medical College and attached Hospitals, Jaipur 
Address  Department of Anesthesiology, SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9269830620  
Fax    
Email  drdivyaghoushlia@gmail.com  
 
Source of Monetary or Material Support  
Deparment of Anesthesiology, SMS Medical College and attached Hospitals, JLN Marg, Adarsh Nagar, Jaipur, Rajasthan 302004 India 
 
Primary Sponsor  
Name  Department of Anesthesiology SMS Medical College and attached Hospitals Jaipur 
Address  Department of Anesthesiology, SMS Medical College and attached Hospitals, JLN Marg, Adarsh Nagar, Jaipur, Rajasthan 302004 India 
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 Divya Ghoushlia  OT 2, second floor, SMS Medical College and attached Hospitals   OT 2, Second floor, JLN Marg, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN 		 9269830620

drdivyaghoushlia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College and attached Hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% bupivacaine(hyperbaric)  Effect of duration of duration of sitting posture in saddle block characteristics and haemodynamic changes with 0.5% bupivacaine(hyperbaric) at every five minutes 
Intervention  0.5% bupivacaine(hyperbaric)  Effect of duration of sitting posture in saddle block characteristics and haemodynamic changes with 0.5% bupivacaine(hyperbaric) at every two minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients undergoing elective perineal surgical procedures.
2)Patients willing to give written informed consent.
3)American Society of Anaesthesiologists (ASA)grade 1 and 2. 
 
ExclusionCriteria 
Details  1)Medically not fit for spinal anesthesia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)To assess and compare the haemodynamic changes from baseline Pulse rate(PR), Blood pressure(BP), Mean arterial pressure(MAP), sPO2.
2)To assess and compare the onset,duration and extent of motor blockade.
3)To assess and compare the onset ,duration and extent of sensory blockade. 		 1)Every 2 minutes for 10 minutes and every 5 minutes until 30 minutes.
2)Every 5 minutes till 30 minutes.
3)Every 5 minutes till 30 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the proportion of cases with side effects.  Every 5 minutes 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   18/07/2024 
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="3"
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 - NO
Brief Summary   The sitting position is used for patients undergoing spinal anesthesia especially when lower lumbar and sacral levels of sensory anesthesia are required. An advantage associated with this position is that the complications associated with it can be reduced. This study assess the relation between saddle block characteristics and haemodynamic changes and duration of sitting position. 
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