| CTRI Number |
CTRI/2025/01/079690 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| 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
|
A comparative clinical study to see the haemodynamic responses to laryngoscopy and intubation with the use of two intravenous drugs |
|
Scientific Title of Study
|
COMPARISION OF INTRAVENOUS LIGNOCAINE AND INTRAVENOUS DEXMEDETOMIDINE IN ATTENUATION OF HAEMODYNAMIC RESPONSES TO LARYNGOSCOPY AND INTUBATION IN CONTROLLED HYPERTENSIVE PATIENT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Popy Borah |
| Designation |
Post graduate trainee |
| Affiliation |
Gauhati Medical Collge and Hospital |
| Address |
Department of Anesthsiology and Critical Care
Gauhati Medical College and Hospital Bhangagarh
Guwahati
Kamrup
Assam
781032
India
Kamrup
ASSAM
781032
India |
| Phone |
6000862537 |
| Fax |
|
| Email |
borahp6991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor, Department of Anesthesiology and Critical Care |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care
Gauhati Medical College and Hospital Bhangagarh
Guwahati
Kamrup
Assam
781032
India
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor, Department of Anesthesiology and Critical Care |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care
Gauhati Medical College and Hospital Bhangagarh
Guwahati
Kamrup
Assam
781032
India
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Bhangagarh, Guwahati-781032,Assam
India |
|
|
Primary Sponsor
|
| Name |
Popy Borah |
| Address |
Gauhati Medical College and Hospital
Bhangagarh
Guwahati-781032,Assam
India |
| 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 Popy Borah |
Gauhati Medical College and Hospital |
Anaesthesiology and Critical Care
Bhangagarh
Guwahati-781032
Kamrup
Assam
India
Kamrup
ASSAM |
06000862537
borahp6991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Gauhati Medical College and Hospital |
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 |
| Comparator Agent |
Dexmedetomidine |
To compare the haemodynamic responses of intravenous dexmetedomidine(1mcg/kg body weight) during laryngoscopy and intubationin pateints undergoing general anesthesia for a total duration of 10minutes after intubation |
| Intervention |
Lignocaine |
To compare the haemodynamic responses of intravenous lignocaine( 1.5mg/kg body weight)during laryngoscopy and intubation in pateint under going general anesthesia for a total duration of 10minutes after intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to age group 18-65 years
2.Patients belonging to ASA grade 2
3.Written and informed consent from the study population.
3.Controlled hypertensive patient on anti hypertensive medication |
|
| ExclusionCriteria |
| Details |
1.Patient with heart rate less than 60beats/minutes
2.Patient with systolic blood pressure less than 100mmhg
3.Patient with anticipated difficult intubation
4.Patient with known cardiac disease except hyprtension
5.Patient with history of renal, hepatic,cerebral disease, peripheral vascular disease, pregnant women and lactating mothers
6.History suggestive of sensitivity to drugs used in the study
7.Intubation attempts lasting more than 30seconds
8.Patient who is on beta blocker drugs as anti hypertensive medication |
|
|
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 compare the various haemodynamic responses in each group, namely heart rate,systolic blood pressure ,diastolic blood pressure,mean arterial pressure,oxygen saturation |
Before induction,during intubation, after 1,3,5 and 10 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the adverse effects (if any)of the drugs studied in each group
2.To evaluate the level of sedation at the time of induction of the patient
|
At the time of induction and post induction |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
15/02/2025 |
| 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="0"
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
|
This is a prospective , double -blind ,randomised control study to be conducted in the operation theatre under the Department of Anaesthesilogy and Critical Care ,GMCH. The study will be carried out on controlled hypertensive adult patients of both sexes , posted for elective surgery. The aim of the study is to compare the efficacy of IV lignocaine and IV dexmedetomidine in attenuation of haemodynamic responses to laryngoscopy and intubation in controlled hypertensive patient. The primary objective is to evaluate the effectiveness of IV lignocaine and IV dexmedetomidine as premedication in attenuating haemodynamic responses in terms of changes in heart rate and mean arterial pressure evoked by laryngoscopy and intubation in controlled hypertensive patients undergoing elective surgeries under general anaesthesia. the secondary objectives are to evaluate the level of sedation and to study any side effects of the drugs. |