| CTRI Number |
CTRI/2025/05/087036 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How the Angle of the Operating Table Affects the Success of Spinal Anesthesia |
|
Scientific Title of Study
|
To Evaluate the Effects of Operation Table Inclination On level of Spinal Anaesthesia blockade. |
| 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 Kriti Sharma |
| Designation |
Junior Resident in Department of Anesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre,
2nd floor,
Department of
Anaesthesiology ,
Gandhi medical college,
Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9068387511 |
| Fax |
|
| Email |
sharmakriti369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Dhawale |
| Designation |
Professor in Department of Anesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre,
2nd floor,
Department of
Anaesthesiology ,
Gandhi medical college,
Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425667373 |
| Fax |
|
| Email |
yashwantdhawalegmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashi Kumari |
| Designation |
Assistant Professor in Department of Anesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre,
2nd floor,
Department of
Anaesthesiology ,
Gandhi medical college,
Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9910946702 |
| Fax |
|
| Email |
shashidhaka8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College,Bhopal, Madhya Pradesh 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Gandhi Medical College,Bhopal, Madhya Pradesh,462001 |
| Type of Sponsor |
Government medical college |
|
|
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 Kriti Sharma |
Hamidia hospital |
2nd floor,Department of Anaesthesiology,Gandhi Medical College,Bhopal,
Bhopal
MADHYA PRADESH |
9068387511
sharmakriti369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Table tilt of 4.5 degree |
Table tilt of specific degree of 4.5 towards the head end
Onset and duration of sensory and motor block is observed |
| Intervention |
Table tilt of 5.5 degree |
Table tilt of specific degree of 5.5 degree towards the head end Onset and duration of sensory and motor block is observed |
| Intervention |
Table tilt of 6.5 degree |
Table tilt of specific degree of 6.5 towards the head end Onset and duration of sensory and motor block is observed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2, BMI less than 28kg per meter square |
|
| ExclusionCriteria |
| Details |
Patient who refuses, patient aged below 18 or above 60, pregnancy, drug allergy, systemic comorbidity, failed block |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation of different degrees/angles of operation table tilt on level of blockade in spinal anaesthesia. |
At baseline, immediately after giving spinal anaesthesia, after 1min, 5min, 10 min, 15 min, 20 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the significance of hemodynamic changes, vital parameters & adverse effects related to spinal anaesthesia |
At baseline, immediately after giving spinal anaesthesia, after 1min, 5min, 10 min, 15 min, 20 min |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2025 |
| 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
|
Spinal Anaesthesia is neuraxial anaesthesia technique in which local anaesthetic is directly placed into subarachnoid space. Spinal anesthesia is only performed in the lumbar spine used for surgical procedures involving the lower abdomen, pelvis, and lower extremities. There is vital importance of patient position acquired during and just after induction of spinal anaesthesia as it can affect level of spinal blockade, hemodynamic changes and other vital parameters. The role of table tilt in subarachnoid block is integral to the success and safety of the anesthesia procedure. During SAB, anesthetic medication is injected into the subarachnoid space, leading to temporary regional anesthesia. Table tilt is crucial for optimizing the patient’s positioning, enhancing the efficacy of the block, and minimizing complications. Table tilt, especially in the Trendelenburg position, promotes the gravitational spread of the anesthetic within the subarachnoid space. This enhances the uniform distribution of the medication, ensuring effective and reliable anesthesia coverage for surgical procedures below the umbilicus level. Spinal anesthesia induces sensory and motor blockade. Monitoring these blockades is crucial to ensure appropriate anesthesia levels.Motor block is monitored by modified Bromage scale. Adjusting the table tilt helps prevent unintended high blocks, reducing the risk of anesthesia affecting higher levels in the spinal cord. This is crucial in averting respiratory complications associated with extensive anesthesia. A clinometer is a measuring tool used to determine angles of inclination or elevation. As most anaesthesiologist are not aware of the degree of tilt given. Once installed, users can calibrate the app and then use their Android device to measure the exact degree of tilt given after sub arachnoid block, thus making tilt given objective and quantitatively documented. In this study we aim to evaluate the correlation of different degrees/angles of operation table tilt on level of blockade and to assess the significance of hemodynamic changes, vital parameters & adverse effects related to spinal anaesthesia |