| CTRI Number |
CTRI/2024/10/074659 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the impact of nebulised dexmedetomidine with nebulised lignocaine on blood pressure on intubation |
|
Scientific Title of Study
|
Randomised trial comparing the efficacy of pre-operative Nebulised Dexmedetomidine with Nebulised Lignocaine in attenuation of hemodynamic pressor response to laryngoscopy and nasotracheal intubation-A Phase II study |
| 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.Pritha Raj |
| Designation |
Assistant Professor |
| Affiliation |
cancer institute |
| Address |
Room No.10,
Department of Anesthesia
Cancer institute WIA
Sardar Patel Road
Adyar Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
09840318716 |
| Fax |
|
| Email |
pritharaj1989@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Pritha Raj |
| Designation |
Assistant Professor |
| Affiliation |
cancer institute |
| Address |
Room No.10,
Department of Anesthesia
cancer institute wia
sardar patel road
adyar chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
09840318716 |
| Fax |
|
| Email |
pritharaj1989@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Pritha Raj |
| Designation |
Assistant Professor |
| Affiliation |
cancer institute |
| Address |
Room No.10,
Department of Anesthesia
cancer institute wia
sardar patel road
adyar chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
09840318716 |
| Fax |
|
| Email |
pritharaj1989@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Cancer Institute WIA,
Sardar Patel Road,
Adyar, Chennai -600020
Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Cancer Institute WIA |
| Address |
Cancer Institute WIA
Sardar patel road adyar
chennai 600020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPritha Raj |
cancer institute |
Room No.10,
Department of anesthesia
Cancer Institute WIA,
Sardar patel road, adyar,
chennai-600020
Chennai
TAMIL NADU |
9840318716
prichink@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Cancer Institute (WIA) Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nebulised dexmedetomidine |
nebulisation done 10 minutes before induction |
| Comparator Agent |
nebulised lignocaine |
nebulised lignocaine 10 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adults, both male and female, aged above 18years, coming for surgery under general anesthesia needing nasotracheal intubation, classified under ASA 1,2 status |
|
| ExclusionCriteria |
| Details |
presence of heart block, asa 3-4, drug allergy to propofool, egg, cardiac dysfunction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the efficacy of nebulised dexmedetomidine with nebulised lignocaine on attenuation of systolic blood pressure in patients undergoing laryngoscopy and nasotracheal intubation |
before drug administration, induction and 10 minutes after nasotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the effect of nebulised dexmed/lignocaine on heart rate, BP, sedation score, need for additional drugs to maintain hemoodynamic stability, the mean of the pre induction and post intubation HR, Mean arterial pressure and diastolic bp shall be compared, mean propofol requirement between the 2 groups shall be compared |
pre drug, induction and 10 minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="2"
Months="0"
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
|
Endotracheal intubation is a highly stimulating procedure associated with a surge in catecholamine levels and significant hemodynamic alterations which may adversely impact postoperative outcomes, especially in patients with multiple comorbidities.Nasotracheal intubation has been found to be more hemodynamic changes due to the involvemnt of highly sensitive structures. Multiple drugs have been used but no ideal drug has been identified. Nebulised dexmedetomidine offers a novel solution to using its properties in attenuating the hemodynamic changes without any of its side effects. Nebulised lignocaine also has been studied extensively wrt to its effect on blunting the intubation response. However, these drugs have not been compared for their effects on nasotracheal intubation. It is being hypothesised that nebulised dexmedetomidine may be more effective than nebulised lignocaine based on previous research. |