| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aqibaliagha8@gmail.com].
- 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.
- 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. |