| CTRI Number |
CTRI/2024/11/077096 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON OF HAEMODYNAMIC RESPONSES IN LATERAL AND SITTING POSITION DURING INDUCTION OF SPINAL ANAESTHESIA FOR CAESAREAN SECTION |
|
Scientific Title of Study
|
COMPARISON OF HAEMODYNAMIC RESPONSES IN LATERAL AND SITTING POSITION DURING INDUCTION OF SPINAL ANAESTHESIA FOR CAESAREAN SECTION: 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 |
Anagha P |
| Designation |
Post graduate |
| Affiliation |
K. S.Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology, K. S. Hegde Medical Academy, Deralakatte post, Mangaluru Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6238913543 |
| Fax |
|
| Email |
anaghaanu2908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Shetty |
| Designation |
Assistant Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology, Justice K S Hegde Charitable Hospital, Nithyananda Nagar, Deralakatte, Mangaluru Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448012303 |
| Fax |
|
| Email |
anilshetty@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anagha P |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology, K S Hegde Medical Academy, Deralakatte post, Mangaluru Dakshina Kannada
Karnataka 575018 India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6238913543 |
| Fax |
|
| Email |
anaghaanu2908@gmail.com |
|
|
Source of Monetary or Material Support
|
| K. S. Hegde Medical Academy, Deralakatte post , Mangaluru, Dakshina Kannada ,575018 , India |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte, Mangaluru, Karnataka |
| 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 |
| Dr Anil Shetty |
Justice K. S. Hegde Charitable Hospital |
Department of Anaesthesiology, Deralakatte, Mangaluru Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9448012303
anilshetty@nitte.edu.in |
|
|
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: O748||Other complications of anesthesiaduring labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of lateral and sitting position during induction of spinal anaesthesia for caesarean section |
I am going to conduct this study on patients posted for Caesarean section. A total of 100 patients will be enrolled for the study. These patients will be divided into 2 groups . Each groups will have 50 patients. One group of the patients will be positioned in sitting for the administration of spinal anaesthesia while the other group will be positioned in lateral for the same. Lumbar puncture will be done in both the groups using 25G quincke babcock needle. Hemodynamic parameters will be noted after the administration of spinal anaesthesia. Patients comfort during the induction will also compared in both positions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant ladies posted for lower segment caesarean section under spinal anaesthesia aged between 18 to 40 years of age |
|
| ExclusionCriteria |
| Details |
Participants refusal to the study, body mass index more than 35, participants with underlying comorbidities like spinal deformity and those who are on anticoagulants, extremely short height less than 140cm and height more than 180cm |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic effects of spinal anaesthesia in lateral and sitting position |
Before induction of spinal anaesthesia and after the induction upto 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the comfort of parturients in lateral & sitting position |
30 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="0"
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
|
| I am going to conduct this study on patients posted for Caesarean section. A total of 100 patients will be enrolled for the study. These participants will be divided into 2 groups . Each groups will have 50 patients. One group of the particiants will be positioned in sitting for the administration of spinal anaesthesia while the other group will be positioned in lateral for the same. Lumbar puncture will be done in both the groups using 25G quincke babcock needle. Hemodynamic parameters will be noted after the administration of spinal anaesthesia. Patients comfort during the induction will also compared in both positions. |
|
| |
|