| CTRI Number |
CTRI/2025/07/090079 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A review of anaesthesia in patients undergoing orthopaedic surgeries for Osteogenesis imperfecta |
|
Scientific Title of Study
|
A Retrospective Review of Anaesthetic Records of Patients with Osteogenesis Imperfecta Undergoing Orthopaedic Procedures over 10 years. A single-center study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anula Dsouza |
| Designation |
Senior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Kasturba Medical College Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9686425707 |
| Fax |
|
| Email |
dsouza.anula@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Shweta Sinha |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of higher education |
| Address |
Kasturba medical college Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9113041764 |
| Fax |
|
| Email |
shweta.sinha@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Shweta Sinha |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of higher education |
| Address |
Kasturba medical college Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9113041764 |
| Fax |
|
| Email |
shweta.sinha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
MAHE Manipal Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Anaesthesia Kasturba medical college MAHE 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 |
| Dr Anula Dsouza |
Department Of Anaesthesia |
Kasturba Medical College Manipal
MAHE Manipal Udupi KARNATAKA |
9686425707
dsouza.anula@manipal.edu |
|
|
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: M358||Other specified systemic involvement of connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All the patients with OI operated between 2015-2024 will be included in the study |
|
| ExclusionCriteria |
| Details |
No exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The impact of three major factors (patient, surgical and anaesthetic) on outcomes such as airway, blood loss, temperature dysregulation, pain and other adverse events will be recorded. |
2015-2025 10 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
15/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/09/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Osteogenesis imperfecta (OI) is a rare, autosomal dominant, inherited connective tissue disorder that affects bones, inner ear and the sclera. Mutations in the collagen type I (COLIA 1) and type II (COLIA 2) genes lead to the development of this disorder. The incidence is about 1 in every 20,000 births. The most common features of this disease include fragile bones, hyperextensible joints, blue sclera, improper dentition and progressive hearing loss it is also associated with conditions like kyphoscoliosis that can lead to cardiopulmonary compromise. These patients mainly present with features that are either skeletal or non-skeletal. Perioperative anesthetic considerations that are of primary concern include: airway challenges, intravenous catheter placement challenges, difficulty performing neuraxial and/or peripheral nerve blockade, significant intraoperative blood loss, hypermetabolism with concern for malignant hyperthermia, and perioperative fracture. Airway management may be difficult. We aim to access the records of OI patients who have undergone major orthopaedic procedures at our center over the last 10 years. Being a rare condition, this study will help throw insight on the Indian scenario and the most common variants of OI, the anaesthetic risks and perioperative challenges for better management. |