| CTRI Number |
CTRI/2024/11/077099 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of dexmedetomidine infusion in the prevention of shivering in patients undergoing caesarean section |
|
Scientific Title of Study
|
DETERMINATION OF THE EFFICACY OF LOW DOSE INTRAVENOUS DEXMEDETOMIDINE FOR PREVENTION OF SHIVERING IN PARTURIENTS UNDERGOING UNDER SPINAL ANAESTHESIA:
RANDOMISED CONTROLLED TRIAL |
| 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 V Nivedha |
| Designation |
Junior Resident |
| Affiliation |
karnataka institute of medical science |
| Address |
Department of Anaesthesiology
department no:206
Karnataka institute of medical sciences
hubbali
Sciences, Hubli Karnataka 580021 India
Dharwad
KARNATAKA 580021
Dharwad
KARNATAKA
580021
India |
| Phone |
8870006773 |
| Fax |
|
| Email |
nivedhavincent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma K S |
| Designation |
Professor |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Department of Anesthesiolgy
Karnataka institute of medical sciences
department no:206
hubbali ,karnataka
India -580021
Dharwad
KARNATAKA
580021
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma K S |
| Designation |
Professor |
| Affiliation |
karanataka institute of medical sciences |
| Address |
Department of Anaesthesiology
Karanataka institute of medical sciences hubbali karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences
hubbali karnataka 580021 India |
|
|
Primary Sponsor
|
| Name |
Karanataka institute of medical science |
| Address |
Department of Anaesthesiology
Karnataka institute of medical science
hubbali 580021
karnataka
India
|
| Type of Sponsor |
Government 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 V Nivedha |
Karnataka institute of medical sciences |
Department of Anesthesiology Karnataka Institute of Medical Sciences, Vidyanagar, Hubli Karnataka 580021 Dharwad KARNATAKA Dharwad
KARNATAKA
Dharwad
KARNATAKA |
8870006773
nivedhavincent@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Karnataka Institute of Medical Sciences, Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O898||Other complications of anesthesiaduring the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LOW DOSE INTRAVENOUS DEXMEDETOMIDINE INTRAOPERATIVELY |
Dose: 0.5mcg/kg of decmedetomidine diluted with 20ml normal saline started intraoperatively after delivery of the baby and cord clamping till the end of surgery |
| Comparator Agent |
NORMAL SALINE INFUSION |
Normal saline infusion intraoperatively till the end of surgery after cord clamping of the baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Parturients with uncomplicated term singleton pregnancy undergoing elective caesarean delivery.
2 . Parturients belonging ot American society of Anaesthesiologists classification I.
3 . Age 18-35 years.
4. Parturients giving informed writen and valid consent. |
|
| ExclusionCriteria |
| Details |
1 . Parturients having hypertensive disorders of pregnancy and diabetes mellitus.
2 . Parturients having BMI>40kg/m2.
3 . Parturients having pre-existing hypo or hyperthermia before operation.
4 . Parturients having hypersensitivity to any of the drugs.
5 . Parturients with cardiac, cerebrovascular , renal and liver disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decreased incidence of shivering after spinal anaesthesia intraoperatively |
The outcomes will be assessed every five minutes till the end of surgery
baseline,5th minute, 10th minute,
15th minute,20th minute,25th minute,30th minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Decreased change in core body temperature intraoperatively and postoperatively
2. Decreased incidence of hypotension intraoperatively, nausea and vomiting postoperatively |
1. shivering until the end of surgery
2. nausea and vomitting headache until the wnd of surgery |
1. Decreased change in core body temperature intraoperatively and postoperatively
2. Decreased incidence of hypotension intraoperatively, nausea and vomiting postoperatively |
1. shivering until the end of surgery
2. nausea and vomitting headache until the wnd of surgery |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
13/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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 Applicable |
| 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 - NO
|
|
Brief Summary
|
Shivering after spinal anaesthesia is a common complication. This leads to redistribution of central heat to the periphery and overall heat loss. Shivering increases oxygen consumption, metabolic rate, carbon dioxide production, lactic acidosis. Also it interferes with electrocardiography, blood pressure, oxygen saturation monitoring and has its detrimental effects on wound healing and coagulation. Dexmedetomidine being a alpha-2 adrenergic receptor agonist, due to its peripheral and central anti -shivering effects , even at a lower dose it can be a useful drug to perioperative shivering in caesarean section patients and it has lesser side effects compared to traditional anti shivering agents
Aim : low dose intravenous administration of dexmedetomidine and placebo (normal saline) in prevention of shivering during spinal anesthesia for lower segment caesarean section patients
Objectives: 1) To compare the incidence of shivering among dexmedetomidine and placebo groups 2) To evaluate the effect of dexmedetomidine on Severity of shivering Body temperature Hypotension hemodynamic parameters
Materials and Methods :A Prospective Double blinded Randomised Controlled Trial
Sample size: 36 in each group |