| CTRI Number |
CTRI/2022/10/046812 [Registered on: 26/10/2022] Trial Registered Prospectively |
| Last Modified On: |
20/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nebulized Lignocaine versus Nebulized Dexmedetomidine in blunting stressor response to intubation |
|
Scientific Title of Study
|
Comparative evaluation of Nebulized Lignocaine with that of Nebulized Dexmedetomidine in blunting haemodynamic response to intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PASUPALA SUBBA KAVYA SREE |
| Designation |
Post graduate student |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
post graduate student,department of anaesthesiology,ims and sum hospital,kalinga nagar,bhubaneshwar,odissa.
ims and sum hospital,kalinga nagar,bhubaneshwar,odissa,751003
Khordha
ORISSA
751003
India |
| Phone |
7386361350 |
| Fax |
|
| Email |
lovelykavya85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SULOCHANA DASH |
| Designation |
PROFESSOR |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
PROFESSOR,DEPARTMENT OF ANAESTHESIOLOGY,IMS AND SUM HOSPITAL,kalinga nagar,bhubaneshwar,odissa
ims and sum hospital,kalinga nagar,bhubaneshwar,odissa,751003
Khordha
ORISSA
751003
India |
| Phone |
9566841303 |
| Fax |
|
| Email |
dr.silu76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PASUPALA SUBBA KAVYA SREE |
| Designation |
Post graduate student |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
post graduate,department of anaesthesiology,ims and sum hospital,bhubaneshwar,odissa
ims and sum hospital,kalinga nagar,bhubaneshwar,odissa,751003
Khordha
ORISSA
751003
India |
| Phone |
7386361350 |
| Fax |
|
| Email |
lovelykavya85@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS AND SUM HOSPITAL ,DEPARTMENT OF ANAESTHESIOLOGY ,PAIN ,PALLIATIVE ANSD CRITICAL CARE K8 ,kalinga nagar ,bhubaneshwar,odisha |
|
|
Primary Sponsor
|
| Name |
PASUPALA SUBBA KAVYA SREE |
| Address |
ims and sum hospital,kalinga nagar,bhubaneshwar,odissa,751003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pasupala Subba kavya sree |
Institute of medical sciences and SUM hospital |
Modular OT complex,1 st floor,dept of anesthesiology,ims and sum hospital, kalinga nagar ,bhubaneshwar
Khordha
ORISSA |
7386361350
lovelykavya85@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulized lignocaine |
4% Lignocaine hydrochloride solution via a facemask and cirrus nebulizer with oxygen at 8 L /min in preoperative room.recordings of HR, SBP, DBP and MAP before nebulization ,before laryngoscopy,immediate laryngoscopy and 3 min interval till 15 min
|
| Comparator Agent |
nebulized dexmedetomidine |
1 mcg /kg of Dexmedetomidine of total 4 ml solution via a facemask and cirrus nebulizer with oxygen at 8 L /min in preoperative room.recordings of HR, SBP, DBP and MAP before nebulization ,before laryngoscopy,immediate laryngoscopy and 3 min interval till 15 min
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 60 years for both sexes belonging to ASA class 1,2 posted for elective surgeries under GA.
|
|
| ExclusionCriteria |
| Details |
1. History of allergies to local anaesthetic agents or to the study drug.
2. Refusal by patient to participate in study
3. Patients of ASA class 3 and 4.
4. Patients with anticipated difficult airway.
5. Baseline heart rate <60 bpm and Blood pressure <90/50(65) mmHg
6. Patients weighing < 40 kg.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the changes in hemodynamic variables (in terms of 20% rise from baseline values) in two groups of patients belonging to both the genders undergoing elective surgeries under general anaesthesia with endotracheal intubation. |
upto 15 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any adverse effects of the drug such as bradycardia, hypotenstion and post operative sedation and sore throat. |
upto 24 hrs postoperatively |
|
|
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)
|
30/10/2022 |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized,double blinded , parallel group trail comparing the efficacy nebulized lignocaine with that of nebulized dexmedetomidine in blunting hemodynamic response to laryngoscopy and intubation in patients undergoing elective surgeries under general anaesthesia. This trial will be conducted in 60 patients with ASA grades 1& 2 in india.The primary outcome is to find out changes in hemodynamic variables in two groups of patients belonging to both the genders undergoing elective surgeries under general anaesthesia with endo tracheal intubation .Secondarily,to study any adverse effects of the drug such as bradycardia,hypotension,and postoperative sedation and sore throat. |