| CTRI Number |
CTRI/2017/11/010415 [Registered on: 07/11/2017] Trial Registered Prospectively |
| Last Modified On: |
07/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing three different dosages of drugs in adult patients planned for General Anaesthesia |
|
Scientific Title of Study
|
Comparison of Rocuronium at two differnt doses and succinylcholine for endotracheal intubation in adult patients for elective surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Henry Prabhu Alfred |
| Designation |
Post Graduate- MD Anaesthesia |
| Affiliation |
Sri Ramachandra Medical College and hospital |
| Address |
Sri Ramachandra University
Porur
Chennai
Sri Ramachandra University
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9884681395 |
| Fax |
044-24765995 |
| Email |
henryalfred23@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof B Ranjith Karthikayan |
| Designation |
MD DNB Anaesthesiology |
| Affiliation |
Sri Ramachandra Medical College and hospital |
| Address |
Sri Ramachandra University
Porur
Chennai
Sri Ramachandra University
Porur
Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841136568 |
| Fax |
044-24765995 |
| Email |
ranjithb73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Henry Prabhu Alfred |
| Designation |
Post Graduate- MD Anaesthesia |
| Affiliation |
Sri Ramachandra Medical College and hospital |
| Address |
Sri Ramachandra University
Porur
Chennai
Sri Ramachandra University
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9884681395 |
| Fax |
044-24765995 |
| Email |
henryalfred23@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College, Hospital & Research
institute
Sri Ramachandra University
Porur
Chennai- 600116 |
|
|
Primary Sponsor
|
| Name |
Ms Meena |
| Address |
Sri Ramachandra University
Porur
Chennai- 600 116 |
| 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 |
| Henry Prabhu Alfred |
Department Of Anaesthesia |
Sri Ramachandra medical college and research institute
Sri Ramachandra university
Porur
Chennai 600 117
Chennai
TAMIL NADU |
9884681395
henryalfred23@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
NIL, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologist Category 1 and 2
Controlled hypertension & Controlled Diabetic with Controlled haemoglobin with Mallamapati grade 1 & 2 for mouth opening.
Cormack-Lehane grading 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Hyperkaelemia
2. Uncontrolled Hypertension
3. Uncontrolled Diabetes
4. Neurological Problems
5. Difficult Airway
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare two doses of rocuronium with succinylcholine with regard to onset of endotracheal intubation in adult patients for elective surgeries |
1. Onset of endotracheal Intubation
2. Intubating condition |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare two doses of rocuronium with suuinylcholine with regard to time taken to intubate and duration of action |
Time taken to intubate
2. Duration of Action |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 1 |
|
Date of First Enrollment (India)
|
08/11/2017 |
| 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="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
|
1. To compare rocuronium with two different doses with succinylcholine with regard to onset of intubating condition in adult patients for elective surgeries.
2. Rocuronium 0.9mg/kg body weight takes 60 sec for intubating conditions wit prolonged actions where as succinylcholine 2mg/kg bodyweight takes 45sec for intubating conditions. Low dose of rocuronium 0.6mg/kg body weight has chosen as it is associated with shorter duration of action. The aim is to find out wether the low dose itself is sufficient to the procedure for intubating conditions.
|