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CTRI Number  CTRI/2022/11/047007 [Registered on: 03/11/2022] Trial Registered Prospectively
Last Modified On: 16/09/2024
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   Amount of propofol required to produce anaesthesia when given with fentanyl or dexmedetomidine with exclusive intravenous drugs 
Scientific Title of Study   A randomised controlled trial to compare the median effect site concentration of propofol with fentanyl or dexmedetomidine for total intravenous anaesthesia in patients undergoing laparoscopic surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Singh 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone    
Fax    
Email  ankitasingh.2315@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nishant Kumar 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Ankita Singh 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone    
Fax    
Email  ankitasingh.2315@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College Shahid Bhagat Singh marg, New Delhi 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg 
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 
Ankita Singh  Lady Hardinge Medical College   Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg
New Delhi
DELHI 
9968667500

ankitasingh.2315@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research,LHMC and Assoc. Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Induction-1mcg/kg Maintenance-0.5mgc/kg/hr till the end of surgical procedure (1 to 3 hours) 
Comparator Agent  Fentanyl  Induction-1mcg/kg maintenance-0.5mcg/kg/hr till the end of surgical procedure(1 to 3 hours) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I and II 
 
ExclusionCriteria 
Details  1. Laparoscopic surgery with an anaesthetic duration of >3hours.
2. Any known allergy to drugs used in the study.
3. BMI > 35.
4. Known psychiatric illness.
5. Addiction to drugs and alcohol.
6. 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 
Mean/ Median effect site concentration (EC50) of propofol with fentanyl or dexmeditomidine will be compared by using Student’s t test/ Mann Whitney U test.   At the end of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1 Number of patients having side effects
2 Mean time to achieve modified aldrete score more than equal to 9
3 Number of patients having post operative nausea vomitting
4 Mean analgesic requirement in post operative period 
1 After stopping total intravenous infusion
2 After stopping total intravenous infusion
3 First 24 hours post operative period
4 First 24 hours post operative period 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/11/2022 
Date of Study Completion (India) 29/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/02/2024 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Results will be published in a scientific journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Total intravenous anesthesia (TIVA) is a technique of general anesthesia which uses a combination of agents given via syringe pump exclusively by the intravenous route without the use of inhalation agents. Propofol-based TIVA techniques offer many advantages including:-lower incidence of post-operative nausea and vomiting, less operating room pollution, reduced emergence delirium, quicker recovery, reduced airway reactivity, laryngospasm and bronchospasm, advocated for neuromuscular disease, core myopathies, muscular dystrophy and reliable delivery using target controlled infusion (TCI)1

A TCI pump contains a microprocessor programmed with pharmacokinetic models for relevant drugs. The user selects the drug and pharmacokinetic model to be used by that TCI pump and inputs the patient characteristics (covariates) such as body weight and age, and the target plasma or ‘brain’ (effect-site) concentration, with the pump determining the initial bolus and subsequent infusion rates. The two most commonly used adult propofol models are Marsh and Schnider2 which utilize the principle of target concentration. The target concentration is the concentration desired in the plasma or at the effect site. The plasma and effect site concentrations are the same at steady-state. The target concentration will differ depending on the magnitude of the desired effect. A propofol effect site concentration of 2 to 3 µg/ml is an appropriate target for sedation, and 4 to 6 µg/ml is adequate for anaesthesia.2 TIVA using TCI can be conducted either with a single drug or with a combination of drugs. Short acting analgesics have to be administered for analgesia along with propofol such as ketamine or dexmedetomidine. Thus, the requirement of propofol is likely to decrease because of synergistic effect.

Different adjuvants when combined with propofol for TIVA have been shown to reduce the effect site concentration of propofol, however, there is limited data on the median effect site concentration of propofol required for anaesthesia along with fentanyl or dexmedetomidine. Therefore, this study is being designed to compare the median effect site concentration of propofol with fentanyl or dexmeditomidine for TIVA.

 
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