| CTRI Number |
CTRI/2024/08/072716 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
TO ASSESS THE EFFECT OF HEIGHT AND POSITION DURING SPINAL ANAESTHESIA IN PATIENTS UNDERGOING NON EMERGENCY TRANSURETHRAL RESECTION OF PROSTATE |
|
Scientific Title of Study
|
Impact of height and position during spinal anaesthesia in patients undergoing elective Transurethral resection of prostrate in teritiary care hospital :A prospective 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 |
Sree Sandhya Maddukuri |
| Designation |
Junior Resident |
| Affiliation |
KMC manipal |
| Address |
Department of Anaesthesiology
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7702148549 |
| Fax |
|
| Email |
sandhya.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Kini |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Anaesthesiology
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845801588 |
| Fax |
|
| Email |
priyanka.kini@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrRajaram Prabhu |
| Designation |
Senior Resident |
| Affiliation |
KMC manipal |
| Address |
Department of Anaesthesiology
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845835499 |
| Fax |
|
| Email |
rajaramprabhu007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital
Madhav Nagar, Manipal,
Karnataka,India
576104 |
|
|
Primary Sponsor
|
| Name |
Dr Sree Sandhya Maddukuri |
| Address |
Department of Anaesthesiology
Kasturba Medical College and Hospital,
Madhav Nagar, Manipal,
Karnataka,India
576104 |
| 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 Sree Sandhya Maddukuri |
Kasturba Medical College and Hospital |
Department of Anaesthesiology
Madhav Nagar, Manipal
576104
Udupi
KARNATAKA |
7702148549
mssandhya.96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Individuals undergoing elective TURP under spinal anesthesia
Age more than 50 years
ASA physical status 1,2and 3
BMI range of 18.5 to 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patient not willing for spinal anesthesia.
Patients not willing for voluntary participation
If procedure is done under general anaesthesia including conversion of spinal anaesthesia to general i/v/o failed spinal or patchy/inadequate block.
Emergency TURP
Known contraindications to spinal anaesthesia.
Patients with spinal deformities
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the effect of patient’s height and position of patient while giving spinal anaesthesia in the level of spread of the anaesthetic drug in patients undergoing elective TURP |
immediate post spinal
after positioning in lithotomy
end of procedure
on shifting patient to postoperative ward
6 hours post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the effect of patient’s height and position of patient while giving spinal anaesthesia in the level of spread of the anaesthetic drug in patients undergoing elective TURP |
immediate post spinal
after positioning in lithotomy
end of procedure
on shifting patient to postoperative ward
6 hours post procedure |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
26/08/2024 |
| 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="1"
Months="6"
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
|
This aims to evaluate the impact of height and position on spread of spinal anaesthesia in patients undergoing elective TURP. patients above 50years belonging to ASA standard 1, 2 and 3 and willing for voluntary participations are being included. Patients undergoing TURP under General anaesthesia,not willing for spinal anaesthesia or voluntary participation in the study or if any known contraindication for spinal anaesthesia are excluded. the level of spinal anaesthesia will be assesd at various intervals to asses the level of spread immediately postspinal, intraoperatively and postoperatively. this helps in evaluating residual anaesthesia level immediate post operative period, to summarize the persistence total duration of the block by documenting the block wear out time |