| CTRI Number |
CTRI/2024/12/078705 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to compare the effect of airway nebulisation with lignocaine and dexmedetomidine on hemodynamic stress response to laryngoscopy and intubation in general endotracheal anaesthesia |
|
Scientific Title of Study
|
Comparison of effect of airway nebulization with lignocaine and dexmedetomidine
on hemodynamic stress response to laryngoscopy and intubation in patients
undergoing elective surgery under general endotracheal anaesthesia – A prospective
randomized double blind 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 Jaisakthivel K S |
| Designation |
Junior Resident |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care, SVIMS, Tirupati.
Chittoor ANDHRA PRADESH 517501 India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
7904242049 |
| Fax |
|
| Email |
drjaisakthivel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peyyety Janaki Subhadra |
| Designation |
Professor |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care, SVIMS, Tirupati. Chittoor ANDHRA PRADESH 517501
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547655 |
| Fax |
|
| Email |
subhadrapeyyety@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peyyety Janaki Subhadra |
| Designation |
Professor |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care, SVIMS, Tirupati. Chittoor ANDHRA PRADESH 517501
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547655 |
| Fax |
|
| Email |
subhadrapeyyety@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati- 517501, Andhra Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Alipiri road, Tirupati- 517501, Andhra Pradesh,India |
| Type of Sponsor |
Other [NIL] |
|
|
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 Jaisakthivel |
Sri Venkateswara Institute of Medical Sciences |
Department of Anaesthesiology Sri venkateswara institute of medical sciences, Alipiri road Tirupati, Andhra pradesh, 517507
Chittoor
ANDHRA PRADESH |
7904242049
drjaisakthivel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences, Tirumala Tirupati Devastanams,T irupati.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 |
Dexmedetomidine nebulisation |
nebulized with Dexmedetomidine 1mcg/kg Twenty minutes prior to induction of anesthesia. |
| Comparator Agent |
lignocaine nebulisation |
nebulized with lignocaine 4% (3mg/kg), twenty minutes prior to induction of anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
patient aged 18 to 65 years
American society of anaesthesiologist status I and II
patient scheduled to undergo surgery of less than 3 hours who require endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to give consent.
2.BMI greater than 30 kg/m2
3.Pregnant and lactating women
4.Patients with known allergy to study drugs.
5.Patients with uncontrolled systemic diseases
6.Anticipated difficult intubation
7.Laryngoscopy more than 20 seconds and more than 1 attempt at intubation are excluded retrospectively
8.Patients having a history of preoperative sore throat or recent upper respiratory tract infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the hemodynamic stress response Heart rate(HR), systolic blood pressure(SBP), diastolic blood pressure (DBP)and mean arterial pressure(MAP) to laryngoscopy and intubation between 4% lignocaine group and Dexmedetomidine group |
at baseline (T0), after induction(T1), immediately after intubation(T2), at 1 min(T3), 2 min(T4), 3min(T5) and 5min(T6) after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the incidence of post operative sedation score using Ramsay sedation score (RSS).
2.To study the incidence of post operative sore throat or cough at 0, 6, 12, 24 hrs after tracheal extubation
3.To study the incidence of post op hoarseness of voice at 0, 6, 12, 24 hrs after tracheal extubation
|
1. Ramsay sedation score at 15,30, 60,90,120,150 minutes after extubation
2.incidence of post operative sore throat or cough at 0, 6, 12, 24 hrs after tracheal extubation
incidence of post op hoarseness of voice at 0, 6, 12, 24 hrs after tracheal extubation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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="1"
Months="0"
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
|
Dexmedetomidine, a selective alpha2-adrenoceptor agonist, is short-acting and has sedative, hypnotic, anxiolytic, analgesic, anti-sialagogue, sympatholytic properties and promotes cardiac, respiratory and neurological stability Lignocaine is an amino- ethylamide and prototype of amide local anesthetic group. It is the most widely used local anesthetic. Showed that its intravenous use blunted pressure response to intubation. Lignocaine is also used in various routes of administration. Lignocaine is also given in nebulization route. Both these drugs are known to decrease the hemodynamic stress response to intubation. The present study is undertaken to study and compare the efficacy lignocaine 4% (3mg/kg) and dexmedetomidine (1mcg/kg) nebulization to attenuate the hemodynamic stress response in patients undergoing elective surgeries under general anesthesia
|