| CTRI Number |
CTRI/2019/10/021560 [Registered on: 09/10/2019] Trial Registered Prospectively |
| Last Modified On: |
09/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of two methods of relaxation for better intubating condition |
|
Scientific Title of Study
|
Assessing the intubating condition based on neuromuscular monitoring versus 3 minutes time after vecuronium induction A Randomised double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uma Sankari |
| Designation |
Postgraduate |
| Affiliation |
Kanyakumari Government Medical college and Hospital |
| Address |
No :31,PG womens hostel
Kanyakumari Government medical College and Hospital
Asaripallam
Nagercoil
Kanyakumari govt medical College and Hospital
Asaripallam
Nagercoil
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9787167161 |
| Fax |
|
| Email |
uma.medicine03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr Edward Johnson |
| Designation |
Head of Department |
| Affiliation |
Kanyakumari Government Medical college and Hospital |
| Address |
Department of Anaesthesiology
Kanyakumari Government medical College and hospital
Asaripallam
Kanyakumari govt medical College and Hospital ,
Asaripallam
Nagercoil
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9443392974 |
| Fax |
|
| Email |
edwardjohnson2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uma Sankari |
| Designation |
Postgraduate |
| Affiliation |
Kanyakumari Government Medical college and Hospital |
| Address |
No 31 PG women Hostel
Kanyakumari Government medical College and Hospital
Asaripallam
Kanyakumari Government medical College and Hospital
Asaripallam
Nagercoil
Kanniyakumari
TAMIL NADU
626123
India |
| Phone |
9787167161 |
| Fax |
|
| Email |
uma.medicine03@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of Anaesthesiology
Kanyakumari Government medical college |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Kanyakumari Government medical College and Hospital Asaripallam |
| 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 Uma Sankari |
Kanyakumari Government Medical college and Hospital |
Department of Anaesthesiology
Additional Block
Kanniyakumari
TAMIL NADU |
9787167161
uma.medicine03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Assessing the intubating condition after 3 minutes of vecuronium induction |
Laryngoscopy and intubation done at end of 3 minutes of vecuronium induction |
| Comparator Agent |
Assessing the intubating condition using neuromuscular monitoring after vecuronium induction |
Laryngoscopy and intubation done when TOF 0 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Written informed consent
ASA PS I and II
Patients scheduled foe elective surgeries under general anaesthesia
Mallampatti grade I and II |
|
| ExclusionCriteria |
| Details |
Patients refusal
ASA PS III and IV
Difficult bag and mask ventilation
Difficult intubation
Facial surgeries
BMI > 30 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the intubating condition at 3 minutes of vecuronium induction compared to intubating condition when TOF of 0 |
Intubating condition may be excellent good or poor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response to intubation in both groups |
Systolic blood pressure
Diastolic blood pressure
Pulse Rate |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/10/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Laryngoscopy and endotracheal intubation during induction of general anaesthesia are extremely strong nociceptive stimuli ,which often lead to unintended stimulation of the sympathetic nervous system.Thus proper assessment of neuromuscular block with a relaxant is of utmost importance for adequate intubating condition.We are traditionally using 3 minutes after vecuronium induction for intubation.But monitoring of neuromuscular conduction appears to be necessary for proper timing of intubation. Aim: To assess whether traditional 3 minutes time is enough to get adequate intubating condition after vecuronium induction. Conclusion:Intubating condition may be better while using neuromuscular monitoring |