| CTRI Number |
CTRI/2023/10/058469 [Registered on: 10/10/2023] Trial Registered Prospectively |
| Last Modified On: |
06/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of preoperative nebulisation of dexmedetomidine on response to laryngoscopy and endotracheal intubation in abdominal surgery under general anaesthesia |
|
Scientific Title of Study
|
Effect of preoperative dexmedetomidine nebulisation on the hemodynamic response to laryngoscopy and endotracheal intubation in elective abdominal surgery under general anaesthesia.A prospective randomized control study at SMS Medical College Jaipur |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trishala Jain |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical college jaipur |
| Address |
room no 101 department of anaesthesia zanana hospital chandpol jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trishala Jain |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical college jaipur |
| Address |
room no 101 department of anaesthesia zanana hospital chandpol jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Kumar Meena |
| Designation |
Junior resident |
| Affiliation |
SMS Medical College |
| Address |
operation theatre 2 department of anaesthesia SMS medical college
Jaipur
RAJASTHAN
302001
India |
| Phone |
7976532973 |
| Fax |
|
| Email |
anilkhokhar1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology SMS Medical college and Attached Hospitals Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology SMS Medical College and Attached Hospitals Jaipur |
| Address |
JLN Marg, Adarsh Nagar Jaipur |
| 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 Anil Kumar Meena |
SMS Hospital |
operation theatre 2 department of anaesthesia sms medical college
Jaipur
RAJASTHAN |
7976532973
anilkhokhar1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College and Attached Hospitals jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
nebulise patient preoperatively with dexmedetomidine 1 microgram per kg bodyweight for 10 min before 30 mintues of surgery then we will asses effect on the hemodynamic response to laryngoscopy and endotracheal intubation and just after and 1 and 3 and 5 7 10 15 min of intubation. |
| Comparator Agent |
Normal saline |
nebulise patient preoperatively with normal saline volume up to 4 ml for 10 min before 30 mintues of surgery then we will asses effect on the hemodynamic response to laryngoscopy and endotracheal intubation and just after and 1 and 3 and 5 7 10 15 min of intubation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients body weight between 40-70 kg and elective surgery under general anesthesia and ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
patient not willing to gave consent and patient with anticipated difficultairway and laryngoscopy time more than 15 seconds ,obese individual bmi more than 30kg per meter square and patirnt with known allergy to dexmedetomidine ,chronic disease hypertension DM ,Patient on beta blocker |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine systolic blood pressure,heart rate, diastolic blood pressure between the groups |
at just before laryngoscopy 1 3 5 7 9 11 15 30 45 min of intubation and just and 1 2 3 hrs of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to asses sedation post operatively between the groups
to asses proportion of cases with complication |
just and 1 2 3 hrs of extubation |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
15/10/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Effect of pre operative dexmetomidine nebulisation on the hemodynamic response to laryngoscopy and endotracheal intubation in elective abdominal surgery under general anaesthesia.Upon arrival in operation theature the written informed consent pac and npo will be confirmed study population 94 wil be randomly divided in to two group by seal envelop method.group A 47 will receive dexmedetomidine 1 microgm kg total 4 ml ns and group B received nebulisation with normal saline 4 ml.then we will check hemodynamic parameter at different time of interval. |