| CTRI Number |
CTRI/2026/01/100516 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of sitting for one minute and two minutes with immediately lying down after spinal anaesthesia on blood pressure in below waist surgeries. |
|
Scientific Title of Study
|
Comparison of one minute and two minute sitting position with immediately lying down on hypotension after subarachnoid block in elective infra umbilical surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thushar P N |
| Designation |
PG resident |
| Affiliation |
Ramaiah medical college |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
MSRIT Post
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
8762341714 |
| Fax |
|
| Email |
tusharnayak007@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prapti Rath |
| Designation |
Associate professor |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
MSRIT Post
Bangalore
560054
Bangalore KARNATAKA 560054 India |
| Phone |
8197007915 |
| Fax |
|
| Email |
praps1985@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Thushar P N |
| Designation |
PG Resident |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
MSRIT Post
Bangalore
560054
Bangalore KARNATAKA 560054 India |
| Phone |
8762341714 |
| Fax |
|
| Email |
tusharnayak007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah medical college
MSRIT post
Bangalore 560054
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Ramaiah medical college |
| Address |
New BEL road
MSRIT post
Bangalore 560054 |
| Type of Sponsor |
Private 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 |
| Thushar P N |
Ramaiah Medical College Hospital |
Department of Anaesthesiology
2nd floor
D block
Teaching hospital
MSRIT Post
Bangalore
Karnataka
560054 Bangalore KARNATAKA |
8762341714
tusharnayak007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (3) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (4) ICD-10 Condition: M165||Unilateral post-traumatic osteoarthritis of hip, (5) ICD-10 Condition: M173||Unilateral post-traumatic osteoarthritis of knee, (6) ICD-10 Condition: M172||Bilateral post-traumatic osteoarthritis of knee, (7) ICD-10 Condition: M201||Hallux valgus (acquired), (8) ICD-10 Condition: M203||Hallux varus (acquired), (9) ICD-10 Condition: M214||Flat foot [pes planus] (acquired), (10) ICD-10 Condition: M216||Other acquired deformities of foot, (11) ICD-10 Condition: N210||Calculus in bladder, (12) ICD-10 Condition: N201||Calculus of ureter, (13) ICD-10 Condition: N209||Urinary calculus, unspecified, (14) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (15) ICD-10 Condition: N430||Encysted hydrocele, (16) ICD-10 Condition: N434||Spermatocele of epididymis, (17) ICD-10 Condition: N471||Phimosis, (18) ICD-10 Condition: N472||Paraphimosis, (19) ICD-10 Condition: N810||Urethrocele, (20) ICD-10 Condition: N811||Cystocele, (21) ICD-10 Condition: N813||Complete uterovaginal prolapse, (22) ICD-10 Condition: N813||Complete uterovaginal prolapse, (23) ICD-10 Condition: N815||Vaginal enterocele, (24) ICD-10 Condition: N816||Rectocele, (25) ICD-10 Condition: N820||Vesicovaginal fistula, (26) ICD-10 Condition: N821||Other female urinary-genital tractfistulae, (27) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patient will be made to lay down immediately after subarachnoid block |
Patients will be made to lay down immediately after subarachnoid block. |
| Comparator Agent |
Sitting position for one minute and two minutes after subarachnoid block |
Patients will be made to sit for 1 minute and 2 minute after subarachnoid block before making them lay down. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All elective infra umbilical surgeries.
ASA grade I and II |
|
| ExclusionCriteria |
| Details |
Spine deformity.
Previous lumbar spine surgery.
Ankylosing spondylitis.
Rheumatoid arthritis.
Pregnancy.
ASA grade III and IV.
Absolute contraindication for subarachnoid block.
Patients on beta blockers, calcium channel blockers.
Height lesser than 150 cms. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hypotension after subarachnoid block in immediately lying down, lying down after one minute sitting position and lying down after two minutes sitting position groups. Parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation of blood will be measured. |
Time in minutes,
At One minute for first ten minutes, every two minutes for next ten minutes, for every five minutes till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the highest level of sensory block in all three groups.
To determine the time taken to reach highest sensory block in all three groups.
To determine the ephedrine requirements in all three groups. |
Time in seconds for sensory block and motor block. |
|
|
Target Sample Size
|
Total Sample Size="123" Sample Size from India="123"
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)
|
18/01/2026 |
| 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="2" 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
|
Subarachnoid block is the most commonly employed technique for infra umbilical surgeries. It is widely accepted due to its ease of administration, reliability and rapid onset. However, hypotension is one of the most common and inevitable complication which occurs immediately after subarachnoid block owing to high intrathecal spread. Incidence of hypotension in normal population is 16 to 33 percent. Various preventive measures have been attempted to reduce incidence of hypotension namely delayed positioning technique, vasopressor addition, fluid preloading and co loading. Delayed positioning technique in post subarachnoid block has shown to have better hemodynamic stability. Various studies have shown that patient who were positioned sitting post subarachnoid block for one minute, two minutes, three minutes and five minutes had less incidence of hypotension. Allowing the patient to remain in sitting position for some time after subarachnoid block delays onset of action, decreased higher dermatomal spread and decreased incidence of hypotension. |