| CTRI Number |
CTRI/2021/08/035376 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
this study is to compare the drug rocuronium which is used for relaxation of muscle in patients undergoing general anaesthesia in planned surgeries |
|
Scientific Title of Study
|
Comparative study of intubating time and
intubating condition using rocuronium with
and without priming technique in patients
undergoing elective surgeries under
general anaesthesia |
| Trial Acronym |
v |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrArun kumar |
| Designation |
associate professor |
| Affiliation |
chettinad hospital and research institute |
| Address |
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India.
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
04447411000 |
| Fax |
04447411011 |
| Email |
pugalenthi08@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArun kumar |
| Designation |
associate professor |
| Affiliation |
chettinad health city |
| Address |
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India.
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9489404818 |
| Fax |
|
| Email |
pugalenthi08@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
drnivethini |
| Designation |
postgraduate |
| Affiliation |
chettinad health city |
| Address |
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India.
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India.
TAMIL NADU
603103
India |
| Phone |
9965872160 |
| Fax |
|
| Email |
nivethini15@gmail.com |
|
|
Source of Monetary or Material Support
|
| chettinad health city, rajiv gandhi salai, kelambakkam,kancheepuram-603103 |
|
|
Primary Sponsor
|
| Name |
chettinad health city |
| Address |
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103, |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| drnivethini |
chettinad health city |
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India.
Kancheepuram
TAMIL NADU |
9965872160
nivethini15@gmail.com |
| DrNivethini |
Chettinad hospital and research institute |
Rajiv Gandhi salami, kelambakkam
Kancheepuram
TAMIL NADU |
9965872160
nivethini15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical 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 |
| Intervention |
Rocuronium with priming and without priming technique |
without priming technique :Group1-0.6mg/kg ( induction dose)
with priming technique :Group 2- 0.06mg/kg as priming dose followedby the remainingg intubation dose
Group 3-0.10mg/kg as priming
dose followed by remaining intubation dose
after that intubating time and intubating condition is compared in 3 groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
elective general anaesthesia cases |
|
| ExclusionCriteria |
| Details |
pregnant women , allergic to study drug, |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| intubating time and intubating condition |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effects |
intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A double blinded prospective study , mainly to compare the intubating time and intubating condition using rocuronium with and without priming techniques. And to know the adverse effects of the drug with this dosage. |