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
|
|
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
|
|
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. |