FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068388 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Investigating Factors That Lead to Shivering During Spinal Anaesthesia in Caesarean Sections 
Scientific Title of Study   Risk Factors for Shivering During Caesarean Section Under Spinal Anaesthesia: An 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  Dr Agha Aqib Ali 
Designation  Post Graduate Resident 
Affiliation  Acharya Shri Chander College of Medical Sciences and Hospital 
Address  Department of Anaesthesiology and Critical Care, Floor no. 6, Acharya Shri Chander College of Medical Sciences and Hospital, Sidhra, Jammu

Jammu
JAMMU & KASHMIR
180019
India 
Phone  8494042042  
Fax    
Email  aqibaliagha8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandita Mehta 
Designation  Head of Department 
Affiliation  Acharya Shri Chander College of Medical Sciences and Hospital 
Address  Department of Anaesthesiology and Critical Care, Floor no. 6, Acharya Shri Chander College of Medical Sciences and Hospital, Sidhra, Jammu

Jammu
JAMMU & KASHMIR
180019
India 
Phone  9419195424  
Fax    
Email  drnanditamehta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Agha Aqib Ali 
Designation  Post Graduate Resident 
Affiliation  Acharya Shri Chander College of Medical Sciences and Hospital 
Address  Department of Anaesthesiology and Critical Care, Floor no. 6, Acharya Shri Chander College of Medical Sciences and Hospital, Jammu

Jammu
JAMMU & KASHMIR
180019
India 
Phone  8494042042  
Fax    
Email  aqibaliagha8@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, Floor no. 6, Acharya Shri Chander College of Medical Sciences and Hospital, Sidhra, Jammu, India, 180019 
 
Primary Sponsor  
Name  Acharya Shri Chander College of Medical Sciences and Hospital 
Address  Department of Anaesthesiology and Critical Care, Floor no. 6, Acharya Shri Chander College of Medical Sciences and Hospital, Sidhra, Jammu, India, 180019 
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 Agha Aqib Ali  Acharya Shri Chander College of Medical Sciences and Hopsital  Department of Anaesthiology and Critical Care, Floor No. 6, Room No. 2, Acharya Shri Chander College of Medical Sciences and Hospital, Sidhra, Jammu, India
Jammu
JAMMU & KASHMIR 
8494042042

aqibaliagha8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Acharya Shri Chander College of Medical Sciences and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Age Group over 18 Years
Patients Undergoing Spinal Anaesthesia 
 
ExclusionCriteria 
Details  ASA 3 or ASA 4
History of Anxiolytic Drug Use
Conversion to General Anaesthesia
Need for Intra Operative Sedation 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Incidence of shivering during caesarean section under spinal anaesthesia  From the time the spinal needle is removed till the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of Shivering  From the time the spinal needle is removed till the end of surgery 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   17/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/06/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aqibaliagha8@gmail.com].

  6. For how long will this data be available start date provided 10-06-2024 and end date provided 10-06-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Shivering is an unpleasant, thoroughly discomforting, and frequent complication after spinal anaesthesia with many grades i.e. from a mild form of having skin eruptions to a severe form with generalized continuous skeletal muscle contractions which can interfere with the monitoring of electrocardiograms, blood pressure (BP), and oxygen saturation. Shivering increases oxygen consumption, lactic acidosis, and carbon dioxide production, decreases patient satisfaction and increases discomfort. Cesarean section is commonly performed under subarachnoid block because of various advantages such as lesser maternal morbidity and mortality, least neonatal exposure to anesthetic drugs, and early maternal and neonatal bonding. The problem is important as it has implications, particularly in the clinical settings of obstetric anaesthesia. In addition to causing an unpleasant feeling and interfering with clinical monitoring, shivering can also increase oxygen consumption by up to 300% and may be associated with a higher risk of surgical site bleeding, cardiac events, wound infections, etc. All of these may result in adverse outcomes for both the mother and fetus.

 A study focusing on various risk factors for shivering during caesarean sections can help to ameliorate this problem and can lead to advancements in anesthesia practice. Anesthesia management techniques may be refined or modified based on the findings of such research. By optimizing anesthesia protocols, healthcare providers can enhance patient comfort, reduce complications, and improve postoperative recovery.

The purpose of this study is to examine the relationship between potential risk factors and the incidence of intraoperative shivering during caesarean section under spinal anaesthesia.

 
Close