| CTRI Number |
CTRI/2024/06/068376 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Finding out the lowest dosage of spinal anaesthetic drug by ultrasound scanning of dural sac cross sectional area in patients undergoing prostate surgery and inguinal hernia surgery |
|
Scientific Title of Study
|
To Modify The Dosage Of Local Anaesthetic drug In The Spinal Anaesthesia With The Help Of Dural SAC Cross Sectional Area Measured By Ultrasound For Transurethral Resection And Inguinal Hernia: A Prospective, Double Blind, Randomised 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 |
PERNI THARUN DASARATH |
| Designation |
Resident |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7396806146 |
| Fax |
|
| Email |
tharundasarathperni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANDIP BAHETI |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANDIP BAHETI |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr.D.Y.PATIL medical college and hospital , pune |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
PERNI THARUN DASARATH |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PERNI THARUN DASARATH |
Dr . D. Y. Patil Medical College Hospital & Research Centre |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
7396806146
tharundasarathperni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS SUB-COMMITTEE , Dr. D. Y. Patil Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Comparing with control group receiving 2 ml 0.5% BUPIVACAINE HEAVY irrespective of dural cross sectional area |
| Intervention |
Bupivacaine |
Using of modified dosage of intrathecal 0.5% BUPIVACAINE HEAVY injection based on dural sac cross section area in TURP and inguinal hernia cases which are done in 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Asa-1,2
Male sex
Age more than 60 years |
|
| ExclusionCriteria |
| Details |
1 Patient refusal for enrolment
2 Infection at the site of injection
3 Patients on anticoagulant therapy
4 Patients with raised intracranial pressure
5 Patients with ASA III ,IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modify The Dosage Of Local Anaesthetic drug In The Spinal Anaesthesia With The Help Of Dural SAC Cross Sectional Area Measured By Ultrasound fo Transurethral Resection And Inguinal Hernia surgeries |
1.To calculate the minimum drug dose requirement of local anaesthetic to achieve T10 blockad
2.To compare sensory level ,compare motor level time,two segment regression time by checking level at every 2.5 minutes of interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modify the dosage Of Local anaesthetic drug to the minimum in the spinal anaesthesia helps in maintaining constant hemodynamics |
To compare intraoperative Mean arterial pressure & Heart rate at every 2 minutes 30 sec interval till 30 minutes & later at every 15 minutes till end of surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/06/2024 |
| 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="1"
Months="0"
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
|
It is a prospective , double blinded, randomised control study to modify the dosage of local anaesthetic drug in the spinal anaesthesia with the help of dural sac cross sectional area by using ultrasound in cases of transurethral resection of prostate and inguinal hernia cases in old age patients to reach level T10. |