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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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