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CTRI Number  CTRI/2024/05/068112 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Analysis of different doses of intravenous dexmedetomidine in decreasing shivering in patients undergoing planned caesarean delivery under central neuraxial anaesthesia. 
Scientific Title of Study   Evaluation of varied doses of Intravenous Dexmedetomidine in attenuating post spinal anesthesia shivering response in patients undergoing Elective Lower Segment Cesarean Section 
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 Vinay Kejdiwal 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anesthesiology, Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7588415795  
Fax    
Email  vinaykejdiwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Sinha 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anesthesiology, Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8879056117  
Fax    
Email  shweta1987.SS95@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinay Kejdiwal 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anesthesiology, Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7588415795  
Fax    
Email  vinaykejdiwal@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal, Karnataka, India - 576104 
 
Primary Sponsor  
Name  Kasturba Medical College, Manipal, MAHE 
Address  Madhav Nagar Manipal Karnataka 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 Vinay Kejdiwal  Kasturba Medical College, Manipal  Department of Anesthesiology, Kasturba Medical College and Hospital, Manipal - 576104
Udupi
KARNATAKA 
7588415795

vinaykejdiwal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
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: O895||Other complications of spinal andepidural anesthesia during the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Intravenous dexmedetomidine 0.2 mcg/kg body weight will be administered once over 10 minutes. 
Comparator Agent  Dexmedetomidine  Intravenous dexmedetomidine 0.5 mcg/kg body weight will be administered once over 10 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  ASA physical status 2 patients above 18 years of age who shiver during elective LSCS that continued to cord clamping 
 
ExclusionCriteria 
Details  Unscheduled caesarean deliveries
History of chronic nausea or itching in pregnancy
Chronic opioid use
History of cardiac, renal or hepatic disease requiring follow up or medications
Coagulation disorders
History of febrile illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Shivering score will be measured according to crossley and mahajan grading for shivering  At 5 minutes interval till 15 minutes and then at 30 minutes and 60 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Sedation score  At 5 minutes interval till 15 minutes and then at 30 minutes and 60 minutes 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
Final Enrollment numbers achieved (Total)= "85"
Final Enrollment numbers achieved (India)="85" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/06/2024 
Date of Study Completion (India) 04/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  
Shivering during Cesarean delivery under neuraxial anesthesia occurs frequently and can be very distressing.  Its origin is both thermogenic and non-thermogenic. Internal redistribution of core temperature, loss of thermoregulatory vasoconstriction below the level of blockade, and a decrease of the vasoconstriction threshold are possible explanations for shivering under neuraxial anesthesia. Active warming methods, such as forced air blankets, are an intuitive and attractive solution to such a problem; nevertheless, studies regarding their effectiveness in the context of parturient undergoing Cesarean delivery have been conflicting and do not address the complex pathophysiology of shivering. 
This study involves the use of drug dexmedetomidine and has been approved by FDA for intravenous use purpose. Through its action on the alpha 2b-adrenoceptor in the hypothalamus, dexmedetomidine suppresses spontaneous firing rate of neurons, decreases central thermosensitivity, and reduces vasoconstriction and shivering thresholds. Two different doses will be compared in terms of time required for observable decrease in shivering caused by central neuraxial block in LSCS patients. Along with shivering, sedation and incidence of adverse events such as nausea, vomiting and respiratory depression will also be compared.
 
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