| 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
|
|
|
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
|
|
|
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. |