| CTRI Number |
CTRI/2017/07/009039 [Registered on: 13/07/2017] Trial Registered Prospectively |
| Last Modified On: |
09/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a study to compare two methods of preventing hypothermia during surgery in patients of head and neck cancer under general anesthesia |
|
Scientific Title of Study
|
Effectiveness of forced air warming and infusion of high dose of amino acid solution on intraoperative hypothermia and coagulation dysfunction in patients undergoing head and neck cancer surgeries: A prospective randomized non-inferiority study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishkarsh Gupta |
| Designation |
Associate professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Department of Onco-Anesthesia and Palliative Medicine
DRBRAIRCh,AIIMS 437 pocket A
Sarita vihar South DELHI 110076 India |
| Phone |
9013310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nishkarsh Gupta |
| Designation |
Associate professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 139, First Floor
Department of Onco-Anesthesiology and Palliative Medicine, DR BRAIRCh, AIIMS Room No 139, First Floor
Department of Onco-Anesthesiology and Palliative Medicine, DR BRAIRCh, AIIMS South DELHI 110076 India |
| Phone |
9013310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nishkarsh Gupta |
| Designation |
Associate professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 139, First Floor
Department of Onco-Anesthesiology and Palliative Medicine, DR BRAIRCh, AIIMS 437 pocket A
Sarita vihar South DELHI 110076 India |
| Phone |
9013310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco-Anaesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS, Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
DRBRAIRCH,Ansari nagar, AIIMS |
| 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 Nishkarsh Gupta |
DrBRAIRCH, aIIMS |
Room NO: 139, Department of Onco Anesthesia and aplliative Medicne, DRBRAIRCH, AIIMS NEW DELHI
South
DELHI South DELHI |
9013310014 9013310014 drnishkarsh@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committe, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group AA5 |
50 patients will receive Amino Acid infusion @ 5 ml/kg/hr till the end of surgery |
| Comparator Agent |
Group FA |
50 patients will be covered with forced air warming blanket till the end of surgery. The normal saline will be given @5ml/hr till the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
100 ASA Grade – I/II patients admitted for major oncological surgeries under general anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Those posted for emergency surgery
2. With known hepatic disease
3. Who had renal disease
4. With known or clinical hypothyroidism or hyperthyroidism
5. With known allergy to drugs used in the study
• With BMI < 20 kg/m2 OR > 30kg/m2
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Core temperature during general anaesthesia in patients undergo major oncological surgeries under general anaesthesia. |
pre induction and every 10 minutes thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Platelet and coagulation pathway as tested by thromo-elastography.
|
every two hours |
Higher dose of AA and FA on perioperative blood loss
|
at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
17/07/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Induction of anaesthesia is
universally associated with hypothermia due to loss of normal thermoregulatory
mechanism. This rapid fall in core temperature during first hour is followed by
a gradual and constant decline in core temperature. Even mild hypothermia may
be deleterious to the patient outcome because of associated myocardial ischemia,
4 prolonged drug actions, 5 coagulopathy6 and
shivering. So we decided to conduct this
study to compare the effects of external heating (forced air warming system)
and internal heat generation (amino acid infusion) in preventing hypothermia
during anesthesia.
After institutional research committee’s
approval this prospective, randomized, study will be conducted in 75ASA Grade –
I/II patients of either sex in the age group of 20 to 65 years admitted for
elective cancer surgery under general anesthesia. The patients will be
randomized into two groups Group
AA4 (N=50): Amino Acid infusion @ 4ml/kg/hr
and Group FA (N=50): forced air warming system will be applied. All the patients will be covered with the drapes. Intravenous
fluids via fluid warmer will be given as per requirement. All the patients will be hooked to
standard monitors in the operating room and anesthesia will be induced with
Propofol 2mg/kg. Airway will be secured after injection vecuronium bromide
(0.1mg/kg). The core temperature of the patients will be recorded pre induction
and every 20 minutes thereafter. OT temperature, mean
intraoperative temperature, presence of intraoperative hypothermia, operative
time, use of blood products, total fluids infused, platelet and coagulation
function as assessed by
thrombo-elastograph and oxygen debt will be noted. The data thus
collected will be expressed as a number or mean ± standard deviation. Patient
characteristics will be compared with chi-square
test. Appropriate tests will be applied for other data and the degree of
hypothermia will be correlated with various variables. |