| CTRI Number |
CTRI/2021/12/038422 [Registered on: 03/12/2021] Trial Registered Prospectively |
| Last Modified On: |
16/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Anaesthesia complications in mother during caesarean section |
|
Scientific Title of Study
|
A study of maternal complications during anaesthesia for caesarean sections in an academic hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hari Naveen A |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Tiger Circle Road, Madhav Nagar, Manipal
Department of Anaesthesiology,
Kasturba Medical College,
Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
harinaveen19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandesh U |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Tiger Circle Road, Madhav Nagar, Manipal
Department of Anaesthesiology,
Kasturba Medical College,
Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
doctorsandesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandesh U |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Tiger Circle Road, Madhav Nagar, Manipal
Department of Anaesthesiology,
Kasturba Medical College,
Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
doctorsandesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education
Tiger Circle Road, Madhav Nagar, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Tiger circle road,
Madhav nagar,
Manipal - 576104 |
| 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 |
| Hari Naveen A |
Kasturba Medical College Hospital |
Medical records department, Woman and children block, Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9940537733
harinaveen19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O742||Cardiac complications of anesthesia during labor and delivery, (2) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, (3) ICD-10 Condition: O747||Failed or difficult intubation foranesthesia during labor and delivery, (4) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Records of Patients who underwent caesarean section, both elective and emergency between October 2018 and April 2019 |
|
| ExclusionCriteria |
| Details |
Patients record having inadequate data of the study parameters |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Study the complications of spinal anaesthesia
2. Study the complications of general anaesthesia |
October 2018 and April 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of level of block to volume of local anaesthetic used with respect to height of the patient |
October 2018 and April 2019 |
|
|
Target Sample Size
|
Total Sample Size="1019"
Sample Size from India="1019"
Final Enrollment numbers achieved (Total)= "1019"
Final Enrollment numbers achieved (India)="1019" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2021 |
| Date of Study Completion (India) |
01/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An audit to study the anaesthetic complications during caesearean section in an academic hospital between October 2018 and April 2019 in Kasturba medical college. |