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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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-skeletalPerioperative 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.

 
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