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CTRI Number  CTRI/2021/02/030967 [Registered on: 03/02/2021] Trial Registered Prospectively
Last Modified On: 02/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two regimens of total intravenous anaesthesia for time to recovery from anaesthesia. 
Scientific Title of Study   Randomised Controlled Trial to compare time to post operative recovery after opioid free total intravenous anaesthesia using propofol with ketamine or dexmedetomidine in patients undergoing elective surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sahir Alam 
Designation  PG Student 
Affiliation  lady hardinge medical college 
Address  DEPARTMENT OF ANAESTHESIOLOGY LADY HARDINGE MEDICAL COLLEGE SHAHEED BHAGAT SINGH MARG NEW DELHI

Central
DELHI
110001
India 
Phone  8287409037  
Fax    
Email  sahir103@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nishant Kumar 
Designation  Professor 
Affiliation  LHMC 
Address  Dept. of Anaesthesiology Shaheed Bhagat Singh Marg

Central
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Nishant Kumar 
Designation  Professor 
Affiliation  LHMC 
Address  Dept. of Anaesthesiology Shaheed Bhagat Singh Marg

North West
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
LADY HARDINGE MEDICAL COLLEGE NEW DELHI 
 
Primary Sponsor  
Name  LADY HARDINGE MEDICAL COLLEGE  
Address  SHAHEED BHAGAT SINGH MARG NEW DELHI 
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 NISHANT KUMAR  LADY HARDINGE MEDICAL COLLEGE  DEPARTMENT OF ANAESTHESIOLOGY SHAHEED BHAGAT SINGH MARG DELHI
Central
DELHI 
9811934659

kumarnishant@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (3) ICD-10 Condition: C16||Malignant neoplasm of stomach, (4) ICD-10 Condition: C17||Malignant neoplasm of small intestine, (5) ICD-10 Condition: C18||Malignant neoplasm of colon, (6) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (7) ICD-10 Condition: C25||Malignant neoplasm of pancreas, (8) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, (9) ICD-10 Condition: E669||Obesity, unspecified, (10) ICD-10 Condition: K45||Other abdominal hernia, (11) ICD-10 Condition: C67||Malignant neoplasm of bladder, (12) ICD-10 Condition: C64||Malignant neoplasm of kidney, except renal pelvis, (13) ICD-10 Condition: K21||Gastro-esophageal reflux disease, (14) ICD-10 Condition: K25||Gastric ulcer, (15) ICD-10 Condition: K26||Duodenal ulcer, (16) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (17) ICD-10 Condition: N25-N29||Other disorders of kidney and ureter, (18) ICD-10 Condition: M84||Disorder of continuity of bone, (19) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  propofol and dexmedetomidine  infusion dexmedetomidine @1mcg/kg over 10 min folowed by infusion dexmedetomidine 0.5mcg/kg/hr. infusion propofol 200mcg/kg/min to maintain a BIS of 40-50 
Comparator Agent  Propofol and Ketamine  INFUSION KETAMINE @1MG/KG OVER 10 MINS FOLLOWED BY INFUSION KETAMINE 0.5MG/KG/HR INFUSION PROPOFOL 200MCG/KG/MIN TITRATED TO MAINTAIN A BIS OF 40-50 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.ASA I and ASA II
2.Undergoing elective surgery of duration 1-4 hours
 
 
ExclusionCriteria 
Details  1.Any known allergy to drugs used in the study.
2.Known psychiatric illness.
3.Narrow angle glaucoma.
4.Addiction to drugs and alcohol.
5.Chronic opioid therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken to achieve Modified Aldrete Score of ≥9 (Mean±SD) using propofol with ketamine or dexmedetomidine  postoperative every minute till Modified Adrette Score is more than or equal to 9 
 
Secondary Outcome  
Outcome  TimePoints 
1.haemodynamic complications (bradycardia, tachycardia, hypotension, hypertension)
2.Mean Bi-spectral index
3.Total propofol requirement (mcg/kg/min; Mean dose±SD)
4.Total 24hrs analgesic requirement
5.post-operative nausea and vomiting
6.irrelevant talk, hallucination
7.explicit recall 
intraoperative haemodynamics every 5 minutes and BIS every 10 min
At the end of surgery and 24 hours postoperative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/02/2021 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Total Intravenous Anaesthesia (TIVA) is a technique of general anaesthesia which uses a combination of agents given exclusively by the intravenous route without the use of inhalation agents. Till recently, inhalational anaesthetic agents have remained the routine choice for maintenance of anaesthesia, but they have their own drawbacks and shortcomings such as cost, different specific vaporizers which require repeated maintenance and scavenging system to prevent pollution of operation room.1 However, in terms of global warming potential, inhalational anaesthetic agents still remain a big hazard for the environment.2 Apart from avoiding these, TIVA decreases post-operative nausea and vomiting (PONV), lessens neurohumoral response, avoids distension of air-filled spaces and postoperative diffusion hypoxemia.1

Opioids are very commonly used in modern methods of anaesthesia. The use of opioids is based on their ability to provide analgesia during the peri operative period.3 Opioids used as the part of a balanced anaesthesia are known to have a lot of side effects such as sedation, respiratory depression, post-operative nausea and vomiting, urinary retention, constipation and opioid induced hyperalgesia.4 These side effects can delay post-operative recovery and early mobilization of the patient. Apart from this opioid are also known for their physical dependence.

Opioid free total intravenous anaesthesia provides a viable alternative for these problems.

The principle of opioid free anaesthesia is to gain analgesic effects from different drugs while minimizing side effects particularly those of opioids,5 with added advantages of decreased postoperative nausea and vomiting and analgesic requirement post operatively.

Ketamine, an NMDA antagonist and dexmedetomidine, an alpha 2 adrenoreceptor agonist have been used in lieu of opioids to provide analgesia intraoperatively. Their use has strengthened the role of opioid free TIVA for maintenance of anaesthesia.

This study is being planned to compare the postoperative recovery profile of patients receiving opioid free TIVA with either ketamine or dexmedetomidine. 
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