| CTRI Number |
CTRI/2021/03/032289 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
21/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To look for differences in perfusion index in lithotomy position during spinal anaesthesia. |
|
Scientific Title of Study
|
A study to evaluate the changes in perfusion index in lithotomy position during spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geeta Ahlawat |
| Designation |
Professor |
| Affiliation |
PANDIT BHAGWAT DAYAL SHARMA UNIVERSITY OF HEALTH SCIENCES, ROHTAK |
| Address |
Department of Anaesthesia, 1st floor, M.S building PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9215810279 |
| Fax |
|
| Email |
drgeetasaroha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitish |
| Designation |
Post graduate student |
| Affiliation |
PANDIT BHAGWAT DAYAL SHARMA UNIVERSITY OF HEALTH SCIENCES, ROHTAK |
| Address |
Department of Anaesthesia, 1st floor, M.S building PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9802957074 |
| Fax |
|
| Email |
5kumarnitish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitish |
| Designation |
Post graduate student |
| Affiliation |
PANDIT BHAGWAT DAYAL SHARMA UNIVERSITY OF HEALTH SCIENCES, ROHTAK |
| Address |
Department of Anaesthesia, 1st floor, M.S building PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9802957074 |
| Fax |
|
| Email |
5kumarnitish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B D Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia |
| Address |
PGIMS Rohtak |
| 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 |
| Nitish |
Pt. B D Sharma PGIMS, Rohtak |
Department of Anaesthesiology, 1st Floor, M.S office building, PGIMS, Rohtak
Rohtak
HARYANA |
9802957074
5kumarnitish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Pt. B D Sharma PGIMS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To look for the changes in perfusion index. |
A study to evaluate the changes in perfusion index in lithotomy position during spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American society of Anaesthesiologists (ASA) grade I and II, planned for surgery under spinal anaesthesia in lithotomy position. |
|
| ExclusionCriteria |
| Details |
Patients having
Contra-indications to spinal anaesthesia
Heart block/ Dysarrhthymia
Morbid obesity
Vertebral deformities
History of neuromuscular disease to lower extremities
Allergy to formulations ingredients
Chronic pain syndromes (taking opioids, anti depressants, anticonvulsants
Will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perfusion index in toe and finger tip |
Baseline, every 15 minutes after spinal anaesthesia till 1 hour post operative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters (HR, NIBP, SpO2) |
Baseline, every 15 minutes after spinal anaesthesia till 1 hour post operative. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/03/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia induces lumbosacral sympathetic blockade leading to vasodilation of the lower limbs. This leads to decrease vascular resistance and decrease cardiac output due to blood pooling in blocked areas of the body. According to the surgery planned, patients put in various positions. Due to this, different hemodynamic and respiratory changes take place. It is therefore important to know the possible physiological effects of position for a safe conduct of anaesthesia. Lithotomy position causes decrease in FRC, lung compliance and transient rise in cardiac output. Therefore it further comprises the already vasodilated limb after spinal anaesthesia. Hence, we plan this study to observe changes in perfusion index in lithotomy position. The study is prospective observational study with a total of 100 patients of age group 18-60 years, of either sex, belonging to American society of Anaesthesiologist (ASA) grade I and II, planned for surgery under spinal anaesthesia in lithotomy position. |