| CTRI Number |
CTRI/2024/10/075178 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Variation in the induction dose and time of propofol on giving inhaled nitrous oxide during induction A prospective randomised controlled study |
|
Scientific Title of Study
|
Variation in induction dose and time of propofol on administering inhaled nitrous oxide during induction A prospective randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siri chandana |
| Designation |
JR 2 |
| Affiliation |
Sri devraj urs medical college |
| Address |
Anaesthesia Department,Sri devraj urs medical college, Tamaka, Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
7330874979 |
| Fax |
|
| Email |
dandamudisirichandana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kiran. N |
| Designation |
Professor |
| Affiliation |
Sri devraj urs medical college |
| Address |
Anaesthesia Department. sri devraj urs medical college, Tamaka, Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
9740468460 |
| Fax |
|
| Email |
dr.nkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siri chandana |
| Designation |
JR 2 |
| Affiliation |
Sri devraj urs medical college |
| Address |
Anaesthesia department,sri devraj urs medical college, Tamaka, Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
7330874979 |
| Fax |
|
| Email |
dandamudisirichandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri devraj urs academy of higher education and research, Tamaka,Kolar,Karnataka,563101 |
|
|
Primary Sponsor
|
| Name |
Shri devaraj urs medical college |
| Address |
Shri devaraj urs medical college, Tamaka, Kolar 563103 |
| 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 Siri chandana |
Sri devraj urs medical college |
Department of
anaesthesia Sri devraj
urs medical college
Tamaka Kolar 563103
Kolar
KARNATAKA
Kolar
KARNATAKA |
7330874979
dandamudisirichandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devraj medical college INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
NIL |
NIL
|
| Intervention |
variation in induction dose and time of propofol on administering inhaled nitrous oxide during induction |
•Patients will be divided into two groups randomly.
Group A : Will receive a mixture of 70% N2O and 30% oxygen via Bains Circuit with 30mg/min(3ml/min) infusion of propofol.
Group B : Will receive a mixture of 100% oxygen via Bains Circuit with 30mg/min(3ml/min) infusion of propofol.
For patients of both groups A and B, a propofol infusion will be started at a rate of 30mg/min(3ml/min).
Duration : Till the patient achieves apnea.
The infusion will be stopped on achieving apnea. The induction time will be calculated from the start of propofol infusion to the apneic state and induction dose as the amount of drug administered in that duration. Patients will be given succinylcholine of 2mg/kg and will be intubated using cuffed endotracheal tube of appropriate size and then maintained with O2,N2O and other inhalational agents.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients proposed for elective surgical procedures under general anaesthesia.
2.ASA 1 and 2
|
|
| ExclusionCriteria |
| Details |
1.Pregnant female.
2.Morbidly obese patients.
3.Patients with allergy to anesthetic agents.
4.Patients with difficult airway.
5.Patients with contraindications to the utilisation of N2O like increased intracranial pressure,obstruction of the bowel, pneumothorax, surgeries of the middle ear.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To evaluate the variation in induction dose of propofol on administering inhaled nitrous oxide |
The dose at which the patient achieves apnea - at 2min or 3 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2) To evaluate the variation in induction time of propofol on administering inhaled nitrous oxide |
the time at which the patient achieves apnea,
The various hemodynamic parameters like HR,MAP,SBP,DBP will be recorded at specific intervals like Preoperatively - T1 ; Before the start of propofol infusion - T2 ; 1 minute after the start of infusion - T3 ; 2 minutes after the start of infusion - T4 ; 3 minutes after the start of infusion - T5 ; 4 minutes after the start of infusion - T6 ; apneic state - T7 ; Before intubation - T8 ; After intubation - T9.
|
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 4 |
|
Date of First Enrollment (India)
|
22/10/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In this study, patients will undergo a comprehensive preoperative assessment, including detailed history taking, physical examination, and routine investigations. An intravenous line will be established, and IV fluids will be administered. The general anesthesia procedure will be explained, and informed consent will be obtained. Patients will be instructed to fast overnight and will receive Tab. Anxit 0.5mg the night before surgery to reduce anxiety.
Upon entering the operating theatre, multipara monitors will be attached to record baseline vital signs, including heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and oxygen saturation (SpO2). Premedication will include Glycopyrrolate 0.2mg and Fentanyl 2mcg/kg, followed by 3 minutes of preoxygenation with 100% oxygen.
Patients will be randomly assigned to one of two groups. Group A will receive a 70% nitrous oxide and 30% oxygen mixture via a Bain’s Circuit, alongside a propofol infusion at 30mg/min (3ml/min). Group B will receive 100% oxygen via a Bain’s Circuit with the same propofol infusion rate. Propofol infusion will be adjusted until the patient reaches an apneic state, with induction time recorded from the start of infusion to apnea and the total dose administered noted.
Following this, succinylcholine (2mg/kg) will be administered for intubation with a cuffed endotracheal tube. Anesthesia will be maintained with a mixture of O2, N2O, and other inhalational agents.
Hemodynamic parameters will be monitored and recorded at various intervals: preoperatively (T1), before propofol infusion (T2), and at 1-minute intervals up to 4 minutes after starting propofol infusion (T3-T6), at apneic state (T7), before intubation (T8), and after intubation (T9). |