| CTRI Number |
CTRI/2020/02/023415 [Registered on: 18/02/2020] Trial Registered Prospectively |
| Last Modified On: |
09/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparison of effects of prewarming in patients of Hysterectomy for prevention of hypothermia |
|
Scientific Title of Study
|
Comparison of effect of prewarming before and after epidural block for prevention of
hypothermia in patients undergoing total abdominal hysterectomy under general anesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand pamnani |
| Designation |
post graduate student |
| Affiliation |
vardhman mahavir medical college and safdarjung hospital |
| Address |
department of anesthesia, safdarjung hospital
South
DELHI
110029
India |
| Phone |
987032033 |
| Fax |
|
| Email |
dranandpamnani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MadhuDayal |
| Designation |
Professor and Specialist Grade I |
| Affiliation |
Safdarjung Hospital |
| Address |
department of anesthesia, safdarjung hospital
South
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MadhuDayal |
| Designation |
Professor and Specialist Grade I |
| Affiliation |
Safdarjung Hospital |
| Address |
department of anesthesia, safdarjung hospital
South
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman mahavir medical college and Safdarjung Hospital, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Department of Anaesthesia, Safdarjung Hospital, New Delhi |
| 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 Anand Pamnani |
Safdarjung Hospital |
VMMC and Safdarjung Hospital, New Delhi
South
DELHI |
9870320335
dranandpamnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Warming Blanket |
These blankets are used for prewarming the patient before anaesthesia and are used to prevent intraoperative hypothermia. The prewarming in one group is for 15 mins and in other group is for 30 min (15 mins before and 15 min after epidural catheter placement) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Female |
| Details |
Patients aged 18-65 years old who fulfil the criteria of physical status I-III American
Society of Anaesthesiologists (ASA grade I-III) scheduled for total abdominal
hysterectomy. |
|
| ExclusionCriteria |
| Details |
1. Known allergy to Local Anaesthetic
2. Infection at site of epidural block. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure incidence of hypothermia by measuring the difference of baseline and
post extubation core body temperature in patients undergoing total abdominal
hysterectomy under general anaesthesia. |
Core body temperature less than 36 Celsius post extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess for shivering by BSAS scale in postoperative period in patients undergoing
total abdominal hysterectomy under general anaesthesia.
- To assess the haemodynamic response of prewarming before and after epidural block
in patients undergoing total abdominal hysterectomy under general anaesthesia. |
- Shivering assessment by BSAS scale in Post operative ward.
-Comparison of haemodynamic response with and without prewarming |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
23/02/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We aim to study the incidence of hypothermia and use of active warming devices in prevention of intraoperative hypothermia and post operative shivering. The purpose is to promote and study the use of active warming devices in prevention of hypothermia. Hypothermia is commonly ignored vital parameter and it has effects on morbidity of the patient and hence to study about it and it prevention is essential. |