| CTRI Number |
CTRI/2018/01/011412 [Registered on: 18/01/2018] Trial Registered Prospectively |
| Last Modified On: |
17/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative study of forced air warmer, ondansetron or their combination on shivering during cesarean section under spinal anaesthesia |
|
Scientific Title of Study
|
A prospective, randomised controlled,comparative study of the effect of forced air warmer,Ondansetron or their combination on shivering during caesarean section under spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Kalyani Suryadhanalakshmi |
| Designation |
Associate Professor |
| Affiliation |
Indian Society of Anaesthesiology |
| Address |
ESIC Medical college and Hospitals,Sanathnagar, Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
7893720606 |
| Fax |
|
| Email |
sksdhanalakshmi@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Kalyani Suryadhanalakshmi |
| Designation |
Associate Professor |
| Affiliation |
Indian Society of Anaesthesiology |
| Address |
ESIC Medical college and Hospitals,Sanathnagar, Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
7893720606 |
| Fax |
|
| Email |
sksdhanalakshmi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Kalyani Suryadhanalakshmi |
| Designation |
Associate Professor |
| Affiliation |
Indian Society of Anaesthesiology |
| Address |
ESIC Medical college and Hospitals,Sanathnagar, Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
7893720606 |
| Fax |
|
| Email |
sksdhanalakshmi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college and Hospitals,Sanathnagar, Hyderabad |
|
|
Primary Sponsor
|
| Name |
ESIC medical college and Hospitals |
| Address |
ESIC Medical college and Hospitals,Sanathnagar, Hyderabad |
| 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 S KALYANI SURYA DHANALAKSHMI |
ESIC Medical college and Hospitals |
Operation theater,Department of Anaesthesiology,ESIC Medical college and Hospitals, Sanathnagar ,Hyderabad
Hyderabad
ANDHRA PRADESH |
7893720606
sksdhanalakshmi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeESICMedicalCollegeHospitalSanathnagarHyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pregnant women coming for lower segment cesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
forced air warmer |
effect of forced air warmer on prevention of shivering in cesarean section patients |
| Comparator Agent |
ONDANSETRON |
ONDANSETRON 4 mg will be given intravenously after the spinal anaesthetic is given and temperature will be monitored.Its effect on prevention of shivering in cesarean section patients will be assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists (ASA) physical Status I and II full-term parturients, 18–35 years old, scheduled for elective lower segment cesarean section surgery under spinal anesthesia will be enrolled in this study. |
|
| ExclusionCriteria |
| Details |
Pregnant women having contraindication to spinal anesthesia, those who have accompanying gestational hypertension, placenta previa, and twin pregnancy, those whose weight will be < 50 kg or > 100 kg,those with cardiopulmonary disease, psychological disorder, and thyroid disorders,those with a recent history of any drugs usage except vitamins and minerals,patients who are likely to receive blood transfusion intraoperatively and with body temperature more than 38°C or <36.5°C will be excluded from the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevention of shivering during cesarean section under spinal anaesthesia |
Preoperatively before entering OT,after entering OT,after administration of Subarachnoid block,at every 5 min interval for first 15min,then at every 15 min interval till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypothermia,nausea and vomiting. |
Preoperatively before entering OT,after entering OT,after administration of Subarachnoid block,at every 5 min interval for first 15min,then at every 15 min interval till the end of surgery |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/02/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Shivering is the one of the most commonly observed complications in anesthesia practice. It has a very high incidence (60 %) in general anaesthesia, whereas the incidence in regional anaesthesia ranges between 40-60 %.In addition, perioperative shivering can occur in up to 85% of patients undergoing cesarean delivery under spinal anesthesia.Hypothermia during regional anesthesia is common and is a cause of shivering. There are three reasons for hypothermia under spinal anesthesia. First, spinal anesthesia leads to internal redistribution of heat from the core to the peripheral compartment . Secondly, with loss of thermoregulatory vasoconstriction below the level of the spinal block, there is increased heat loss from body surfaces. Lastly, there is altered thermoregulation under spinal anesthesia characterized by a 0.5oC decrease in vasoconstriction and shivering thresholds .However, redistribution can be prevented by cutaneous warming. Warming markedly increases peripheral tissue heat content and reduces the core-to-peripheral tissue temperature gradient , which affects temperature .Recently, it has been established that one of the various pathways involved in Post anesthesia shivering is through the 5-HT3 receptor, so 5-HT3 antagonist must have a role in prevention PAS. After obtaining informed consent, 120 full term parturients women who are eligible to participate in the study will be be allocated randomly using closed envelope technique to one of three groups:Group O (n=40): will Receive Injection Ondensetron 4mg iv . just after giving block with no forced air warmingGroup W (n=40): will Receive upper body forced-air warming set at 42°c after giving block without Injection Ondensetron and warming device is continued till end of surgery.Group C (n=40): will recieve Injection Ondensetron 4mg (I.V. just after giving block) plus active forced-air warming after giving block to end of sugery. we will monitor core temperature(tymphanic membrane) and skin temperature during surgery at regular intervals. Grades of shivering will also be noted and compared between the groups.
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