| CTRI Number |
CTRI/2024/11/077453 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the anesthetic effects of different doses of spinal anaesthesia of inj. hyperbaric bupivacaine 0.5 percent for patients undergoing caesarean section |
|
Scientific Title of Study
|
A prospective observational study to assess the anesthetic effects of different doses of intrathecal hyperbaric 0.5 percent bupivacaine for singleton caesarean section |
| 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 Fulbestar Lyngdoh |
| Designation |
MD student |
| Affiliation |
Government Medical college surat |
| Address |
Department of Anaesthesiology, Government Medical College and New civil Hospital, Surat
Surat
GUJARAT
395001
India |
| Phone |
8309264970 |
| Fax |
|
| Email |
fulbester@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunaina Patel |
| Designation |
Associate professor and Guide |
| Affiliation |
Government Medical college, Surat |
| Address |
Department of Anaesthesiology, Government Medical College and New civil Hospital, Surat
Surat
GUJARAT
395001
India |
| Phone |
9825143013 |
| Fax |
|
| Email |
patel_sunaina@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunaina Patel |
| Designation |
Associate professor and Guide |
| Affiliation |
Government Medical college, Surat |
| Address |
Department of Anaesthesiology, Government Medical College and New civil Hospital, Surat
Surat
GUJARAT
395001
India |
| Phone |
9825143013 |
| Fax |
|
| Email |
patel_sunaina@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, surat, Gujarat, India.
Pincode-395001 |
|
|
Primary Sponsor
|
| Name |
Dr Fulbestar Lyngdoh |
| Address |
Department of Anaesthesiology, Government Medical College and New civil Hospital, near majuragate, Surat, Gujarat, India.
pincode-395001 |
| 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 Fulbestar Lyngdoh |
Government Medical College, Surat. |
Department of Anaesthesiology, Government Medical College and New civil Hospital, Surat
Surat
GUJARAT |
8309264970
fulbester@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HREC,GOVERNMENT,MEDICALCOLLEGE,SURAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pateints posted for singelton ceasarean section, belonging to Asa class I,II or III |
|
| ExclusionCriteria |
| Details |
Patients having major cardio pulmonary disorders or hepato renal disorders
patients with multifetal pregnancy, hand or cord proplapse
patients weight less than 40kgs or more than 90kgs
patients height less then 140cm or more than 190cm |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Motor and Sensory characteristics in all three groups
2. Hemodynamics parameters in all three groups |
1. Motor and Sensory characteristics in all three groups at the time of spinal anaesthesia upto the effects which weared off possibly between 1-4 hours
2. Hemodynamics parameters in all three groups after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Maternal satisfaction
2. Obsterics satisfaction |
baseline |
|
|
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)
|
12/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A prospective observational study to assess the anesthetic effects of different doses of intrathecal hyperbaric bupivacaine 0.5% for singleton caesarean section. Comparing different doses of Hyperbaric bupivacaine given in spinal anesthesia in three groups for Motor, Sensory and Hemodynamics effects of the patient. |