| CTRI Number |
CTRI/2020/02/023568 [Registered on: 25/02/2020] Trial Registered Prospectively |
| Last Modified On: |
09/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out if addition of lignocaine 1.5mg/kg IV improves intubating condition compared to rocuronium 0.6mg/kg IV at 60s after induction. |
|
Scientific Title of Study
|
Comparative study of intubating conditions between low dose rocuronium (0.6mg/kg) and rocuronium (0.6mg/kg) with lignocaine (1.5mg/kg) in adults at 60s after induction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Varghese |
| Designation |
Professor |
| Affiliation |
Amrita institue of medical sciences |
| Address |
Amrita institute of medical sciences Ponekkara Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447325249 |
| Fax |
|
| Email |
rekhavarghese@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha Varghese |
| Designation |
Professor |
| Affiliation |
Amrita institue of medical sciences |
| Address |
Amrita institute of medical sciences Ponekkara Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447325249 |
| Fax |
|
| Email |
rekhavarghese@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sneha S |
| Designation |
MD resident |
| Affiliation |
Amrita institute of medical sciences |
| Address |
Amrita institute of medical sciences Ponekkara Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9900331854 |
| Fax |
|
| Email |
sneha9793@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department fund amrita institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Amrita hospital |
| Address |
Amrita institute of medical sciences Ponekkara Kochi 682041 |
| 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 |
| Sneha S |
Department of anaesthesia |
Amrita institute of medical sciences Ponekkara Kochi 682041
Ernakulam
KERALA |
9900331854
sneha9793@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To evaluate if addition of 1.5mg/kg lignocaine improves intubating conditions compared to 0.6mg/kg rocuronium in adults at 60s after induction. |
1.5mg/kg IV lignocaine will be given to one group of patients receiving 0.6mg/kg rocuronium which will be compared to the other group receiving 0.6mg/kg rocuronium alone. |
| Comparator Agent |
To evaluate if addition of 1.5mg/kg lignocaine improves intubating conditions compared to 0.6mg/kg rocuronium in adults at 60s after induction. |
1.5mg/kg IV lignocaine will be given to one group of patients receiving 0.6mg/kg rocuronium which will be compared to the other group receiving 0.6mg/kg rocuronium alone. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60years
ASA I-II |
|
| ExclusionCriteria |
| Details |
Difficult airway
Patients considered full stomach
Neurological disorders
BMI >30
When intubation lasts for more than 15s |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate if addition of 1.5mg/kg lignocaine improves intubating conditions compared to 0.6mg/kg rocuronium in adults at 60s after induction. |
February 2020 to August 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic response mean arterial pressure and heart rate between the two groups. |
February 2020 to August 2020 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2020 |
| 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="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rocuronium is a non depolarizing muscle relaxant used for rapid sequence induction in conditions where succinylcholine is contraindicated. In this randomised control study we would be looking forward to find out if addition of 1.5mg/kg lignocaine provides smooth intubating conditions compared to 0.6mg/kg rocuronium. We would also be looking at the hemodynamic response between both the groups. |