| CTRI Number |
CTRI/2025/07/091339 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Anesthetic Dose and Duration Using Propofol MCT/LCT with Nitrous Oxide in ENT Procedures
|
|
Scientific Title of Study
|
To evaluate the dose and time requirement of Propofol medium chain triglygeride- long chain triglyceride (MCT - LCT) with co-administartion of nitrous oxide (N2O) during induction of general anesthesia in Ear, Nose and Throat (ENT) surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Sareen |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical college, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7838803954 |
| Fax |
|
| Email |
nikitasareen1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayashree Sen |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical college, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9813061192 |
| Fax |
|
| Email |
jayashree_sen@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayashree Sen |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical college, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9813061192 |
| Fax |
|
| Email |
jayashree_sen@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi, Meghe, Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private 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 Nikita Sareen |
Jawaharlal Nehru Medical College |
Department of Anesthesiology, Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha
Wardha
MAHARASHTRA |
7838803954
nikitasareen1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nitrous oxide (N2O) |
N2O is safe as a anxiolytic and analgesic but has untoward effect such as second gas effect, diffusion hypoxia, post oprative nausea and vomitting |
| Intervention |
Propofol will be given at induction |
Propofol is effective and safe having hypnotic as well as amnesic properties. It is fast in onset, has short half life. Less injection site pain is reported with MCT-LCT preparations as compared to LCT preprations |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA one and two undergoing surgeries requiring general anesthesia for elective nose and throat surgeries with controlled ventilation
weight forty to eighty kg
no comorbidities
|
|
| ExclusionCriteria |
| Details |
body mass index more than thirty five
renal insufficiency
liver dysfunction
patient with anticipated difficult airway
cardiorespiratory abnormalities
pregnant,breast feeding female
history of sleep apnoea
middle ear surgery
emergency surgery in neck and oral cavity
patient receiving other form of analgesia
undergoing surgical operations with significant hemodynamic changes |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy and safety of induction dose of propofol when N2O is been concurrently administered |
2-5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the hemodynamic variations to therapeutic dose of propofol and any adverse effects during the induction process |
6 minutes |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of study is to evaluate Anesthetic Dose and Duration Using Propofol MCT/LCT with Nitrous Oxide in ENT Procedures. The co-administration of N2O in fresh gas flow during induction of anesthesia is expected to reduce the induction dose and time of propofol MCT-LCT |