| CTRI Number |
CTRI/2021/08/035734 [Registered on: 17/08/2021] Trial Registered Prospectively |
| Last Modified On: |
11/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of effectiveness of preoperative Dexmedetomidine nebulization vs Lignocaine nebulization on blood pressure and heart rate changes to laryngoscopy and tracheal intubation |
|
Scientific Title of Study
|
Evaluation of efficacy of preoperative Dexmedetomidine nebulization vs Lignocaine nebulization on hemodynamic changes to laryngoscopy and tracheal intubation - a prospective randomized clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvisha Mendpara |
| Designation |
Resident Doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College and SSG Hospital, Vadodara |
| Address |
Department of Anaesthesiology, Government Medical College and SSG Hospital, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
09328224929 |
| Fax |
|
| Email |
urvishapatel7114@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Patel |
| Designation |
Associate professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College and SSG Hospital, Vadodara |
| Address |
Department of Anaesthesiology, Government Medical College and SSG Hospital, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Patel |
| Designation |
Associate professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College and SSG Hospital, Vadodara |
| Address |
Department of Anaesthesiology, Government Medical College and SSG Hospital, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Vadodara |
|
|
Primary Sponsor
|
| Name |
Urvisha Mendpara |
| Address |
Q802, Darshanam Cetral Park, Saiyajigunj, Vadodara |
| 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 Urvisha Mendpara |
government medical college and SSG hospital vadodara |
First floor, Surgery and orthopedic operation room , new surgical building, SSG hospital, vadodara
Vadodara
GUJARAT |
09328224929
urvishapatel7114@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research (IECBHR) Medical College & SSG Hospital, Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preoperative Dexmedetomidine nebulization |
Preoperative Dexmedetomidine nebulization in dose of 1microgram per kg with 4ml normal saline just 30 minutes prior giving anesthesia to blunt the hemodynamic response to laryngoscopy and tracheal intubation in general anesthesia |
| Comparator Agent |
Preoperative Lignocaine nebulization |
Preoperative Lignocaine nebulization in dose of 3milligram per kg + 3 ml normal saline done 30 mins prior giving anesthesia to blunt the hemodynamic response to laryngoscopy and tracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgery under general anesthesia requiring endotracheal intubation
ASA grade 1 & 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal, nasal deformity or nasal blockade, pregnancy , obesity, known or anticipated difficult intubation, requiring more than 2 attempts of intubation or more than 20 sec for laryngoscopy, hypertensive patients, allergic to Dexmedetomidine or Lignocaine |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure in response to laryngoscopy and tracheal intubation |
Observe heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure at time of laryngoscopy , 1 min ,3 min, 5 min and 10 min after that |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe effects on rate pressure product or side effects if any |
At time of laryngoscopy, 1min ,3min ,5min and 10 min after that |
|
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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)
|
22/08/2021 |
| 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="7"
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)?
Response - NO
|
|
Brief Summary
|
Aim of study is to know efficacy of preoperative Dexmedetomidine nebulization vs Lignocaine nebulization on reducing heart rate and blood pressure in response to laryngoscopy and tracheal intubation Patients suitable for study as per inclusion and exclusion criteria from SSG hospital will be selected Demographic details, history, investigation will be assesed and general and systemic examination will be done Patients will be randomly divided in two groups One group will be nebulized with Dexmedetomidine 1microgram per kg diluted upto 5ml with 0.9% normal saline 30 min before induction of anesthesia and the other group will be nebulized with 4% Lignocaine 3 milligram per kg 30in before induction of anesthesia Heart rate, systolic and diastolic blood pressure and mean arterial pressure will be monitored before laryngoscopy , at the time of laryngoscopy and 1min, 3min, 5min and 10 min afterwards |