| CTRI Number |
CTRI/2018/01/011470 [Registered on: 22/01/2018] Trial Registered Prospectively |
| Last Modified On: |
19/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
effects of atropine in suppressing negative haemodynamic effects |
|
Scientific Title of Study
|
A prospective randomised study to assess whether prophylactic atropine administration attenuates the negative haemodynamic effects of induction of anaesthesia with propofol and fentanyl. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Dinesh kumar |
| Designation |
Post Graduate Student |
| Affiliation |
kanyakumari govt medical college |
| Address |
Department of anaesthesiology
Kanyakumari govt medical college COLLEGE
Asaripallam
Nagercoil
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9597858452 |
| Fax |
|
| Email |
dinambbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Edward Johnson |
| Designation |
Guide |
| Affiliation |
Kanyakumari govt medical college |
| Address |
Department of anaesthesiology
Kanyakumari Govt Medical College
Asaripallam
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9443392974 |
| Fax |
|
| Email |
edwardjohnson2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Dinesh kumar |
| Designation |
|
| Affiliation |
kanyakumari govt medical college |
| Address |
department of anaesthesiology
Kanyakumari Govt Medical College
asaripallam
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9597858452 |
| Fax |
|
| Email |
dinambbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Head of the department
Kanyaumari govt medical college
Asaripallam
Kanyakumari |
|
|
Primary Sponsor
|
| Name |
Head of the department |
| Address |
department of anaesthesiology
kanyakumari govt medical college
asaripallam
kanyakumari |
| 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 |
| Dr S Dinesh kumar |
Kanyakumari Goverment Medical College Hospital. |
department of anaesthesiology
Kanyakumari Govt Medical College
Asaripallam
Kanniyakumari
TAMIL NADU |
9597858452
dinambbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee,kanyakumari govt medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atropine |
Atropine 0.6mg
Intravenous route
Single dose
Before the induction of anaesthesia
Monitored for 15 mins |
| Comparator Agent |
Normal saline |
Normal saline 1 cc
Intravenous route
Single dose
Given just before induction of anaesthesia
Monitored for 15 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients posted for elective surgery
2 ASA I and II
|
|
| ExclusionCriteria |
| Details |
1 ASA III and IV
2 Patients with contraindications of atropine
3 Patients with IHD/CAD/DIABETIC NEUROPATHY
4 Patients with ECG showing tachyarrythmias
5 Emergency surgeries
6 Mallampatti grade III and IV
7 BMI>35
8 Anticipated difficult airway
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Atropine attenuates the fall in BP HR and MAP during induction of anaesthesia with propofol and fentanyl |
Starting point Time of induction with propofol and fentanyl
End point Monitored every minute till 15 mins after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/01/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim To study the effect of atropine in suppressing the negative haemodynamic effects of induction agents with propofol and fentanyl during general anaesthesia Materials and methodology patients posted for elective surgery are selected divided into two groups group A receiving atropine 0.6mg/ml 1cc group S receiving saline 1cc Intervention All patients will be kept on NPO status for 8 hrs before surgery Patients will be randomized into two groups using closed envelope technique On arrival to operation theatre ECG NIBP SPO2 will be connected IV line with 18G cannula will be secured in any of the preipheral veins of upper limbs Infusion of 500 ml crystalloid will be completed before induction of anaesthesia Pateints will be premedicated with inj.midaz 1mg Patients will be preoxygenated with 3 litres of o2 through face mask Atropine or saline will be given according to the group assigned Patients will be induce with Propofol 100mg and fentanyl 100mcg Patients will be ventilated at a tidal volume of 8ml/kg with 4 litres o2 for 5 mins after administration of atracurium 0.5mg/kg Then patients will be intubated with appropriate size cuffed ET tube Baseline BP HR MAP will be recorded All the above will be monitored every minute till 15 mins after induction.
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