| CTRI Number |
CTRI/2022/08/044610 [Registered on: 03/08/2022] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Atracurium dose efficacy & timing comparision in rapid sequence intubation |
|
Scientific Title of Study
|
DETERMINATION OF DOSE AND EFFICACY OF ATRACURIUM FOR RAPID SEQUENCE INDUCTION OF ANAESTHESIA: A RANDOMIZED PROSPECTIVE STUDY" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANCHALA PRIYANKA |
| Designation |
MBBS MD ANAESTHESIOLOGY PURSUING |
| Affiliation |
BLDE deemed to be university Vijayapura Karnataka |
| Address |
BLDE(DU)S SHRI B.M PATIL MEDICAL COLLEGE, HOSPITAL &RESEARCH CENTRE, VIJAYAPURA-586103 KARNATAKA
BLDE university vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9963769249 |
| Fax |
|
| Email |
priyankamanchala100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAYKUMAR TK |
| Designation |
PROFESSOR OF ANAESTHESIOLOGY |
| Affiliation |
BLDE deemed to be university |
| Address |
PROFESSOR DEPARTMENT OF ANAESTHESIOLOGYBLDE SHRI BM PATIL MEDICAL COLLEGE AND HOSPITAL AND REAEARCH CENTER
blde deemed to be university
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
drvijay8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANCHALA PRIYANKA |
| Designation |
MBBS MD ANAESTHESIOLOGY PURSUING |
| Affiliation |
BLDE deemed tobe university |
| Address |
BLDE SHRI BM PATIL MEDICAL COLLEGE AND HOSPITAL AND RESEARCH CENTER
BLDE DEEMED TO BE UNIVERSITY vijayapura 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9963769249 |
| Fax |
|
| Email |
priyankamanchala100@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI B.M.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
Manchala priyanka |
| Address |
Shri Bm patil medical collage and hospital |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Priyanka Manchala |
SHRI B.M.PATIL MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE |
Department OF anaesthesiology
Bijapur
KARNATAKA |
9963769249
priyankamanchala100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI B.M.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O666||Obstructed labor due to other multiple fetuses, (2) ICD-10 Condition: K652||Spontaneous bacterial peritonitis, (3) ICD-10 Condition: J439||Emphysema, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atracurium |
DOSE OF 0.75MG/KG IV loading dose for intubation |
| Comparator Agent |
ATRACURIUM |
DOSE OF 1MG/KG IV loading dose for intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 20 to 65 years of ASA grades I and II of both sexes |
|
| ExclusionCriteria |
| Details |
Patients of ASA grades III and IV.
Age less than 20 years and greater than 65 years |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for intubation in 0.75mg/kg/mim vs 1mg/kg/min doses comparision |
time taken for intubation 60sec 90sec 120sec |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ease of intubation and cardiovascular haemodynamics in 0.75mg/kg/mim and 1mg/kg/min |
preinduction 1min 3min 5min
pre intubation 1min 3min 5min
post intubation 1min 3min 5min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/10/2022 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Atracurium doses comparison in rapid sequence induction of anaesthesia |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Atracurium group A :0.75mg/kg Atracurium group B:1mg/kg
AIM OF STUDY
1)In both the groups, i will compare the heart rate mean arterial preesure ,ease of intubation cardiovasular and respiratory haemodynamics and will check which one is better
2)time taken for intubation in diffirent doses comparision also will be checked
|