| CTRI Number |
CTRI/2024/10/075144 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare intubating conditions with and without priming with rocuronium |
|
Scientific Title of Study
|
A prospective randomized study in comparing intubating conditions with and without priming with rocuronium |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Imnasenla Ozukum |
| Designation |
JR2 |
| Affiliation |
Gajra Raja Medical college, Gwalior, Madhya Pradesh |
| Address |
Department of anaesthesiology, GRMC, Gwalior, Madhya Pradesh,474009,India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8416089290 |
| Fax |
|
| Email |
imnasenlaozukum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Goyal |
| Designation |
Professor and Head of department |
| Affiliation |
Gajra Raja Medical college, Gwalior, Madhya Pradesh |
| Address |
Department of anaesthesiology, GRMC, Gwalior, Madhya Pradesh,474009,India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9424455330 |
| Fax |
|
| Email |
drpreetiravigoyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Imnasenla Ozukum |
| Designation |
JR2 |
| Affiliation |
Gajra Raja Medical college, Gwalior, Madhya Pradesh |
| Address |
Department of anaesthesiology, GRMC, Gwalior, Madhya Pradesh,474009,India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8416089290 |
| Fax |
|
| Email |
imnasenlaozukum@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajra raja medical college, Gwalior, Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Imnasenla Ozukum |
| Address |
Department of anaesthesiology, GRMC, Gwalior, Madhya Pradesh, 474009, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Imnasenla Ozukum |
Gajra raja medical college and JAH hospital |
Department of anaesthesiology, GRMC, Gwalior, Madhya Pradesh, 474009
Gwalior
MADHYA PRADESH |
8416089290
imnasenlaozukum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Gajra raja medical college, Gwalior |
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 |
| Comparator Agent |
Normal saline |
Normal saline will be given instead of priming dose prior to giving intubating dose of 0.6mg/kg rocuronium intravenously during intubation. |
| Intervention |
Rocuronium |
One tenth of intubation dose of rocuronium 0.06mg/kg rocuronium as priming dose to be given intravenously 3minutes prior to giving remaining intubating dose of 0.54mg/kg rocuronium. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing general anaesthesia giving consent to participate in study and age group between 18 to 60 years with mallampati grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Age more than 65 years
History of allergy to rocuronium
History of patients receiving drugs interfering with neuromuscular action
Obesity
Mallampati grade 3 and 4
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Rocuronium 0.06mg/kg is expected to produce acceptable intubating conditions (good or excellent).
|
60 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Rocuronium is expected to not show any adverse hemodynamic response.
|
60 seconds |
|
|
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)
|
10/09/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study ’ A prospective randomised study in comparing intubating conditions with and without priming with rocuronium’, will be conducted in Gajra raja medical college, Gwalior MP on sample size of 60. 30 patients each will be divided in Group A and Group C. Group A will receive 0.06mg/kg priming dose before giving intubating dose of rocuronium and Group C will be given normal saline before giving intubating dose of rocuronium. Vital parameters like heart rate, blood pressure, mean arterial pressure , pulse oximetry (Spo2) will be observed at baseline,1min,2min,3min,4min and 5min after intubation. After the study, end results will be obtained . So ,in this study , we are comparing intubating conditions, hemodyamic changes and adverse effects of rocuronium using priming technique during intubation. |