| CTRI Number |
CTRI/2024/01/062160 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effects of dexmedetomidine and lignocaine on changes in heart rate and blood pressure during removal of endotracheal tube in abdominal surgeries |
|
Scientific Title of Study
|
Comparison on the effects of I.V. dexmedetomidine versus I.V. lignocaine on haemodynamic responses during tracheal extubation in abdominal surgeries |
| 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 Prantik Deb |
| Designation |
Post Graduate Trainee |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care , Silchar Medical College and Hospital, Ghungoor, Silchar , Cachar, Assam
Cachar
ASSAM
788014
India |
| Phone |
8399989633 |
| Fax |
|
| Email |
prantikdeb1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneeta Dutta |
| Designation |
Professor and HOD |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Silchar Medical and Hospital, Ghungoor, Silchar, Cachar, Assam
Cachar
ASSAM
788014
India |
| Phone |
9435074110 |
| Fax |
|
| Email |
drsuneetadutta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneeta Dutta |
| Designation |
Professor and HOD |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Silchar Medical and Hospital, Ghungoor, Silchar, Cachar, Assam
Cachar
ASSAM
788014
India |
| Phone |
9435074110 |
| Fax |
|
| Email |
drsuneetadutta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar Medical College and Hospital , Silchar , Cachar , Assam Pin - 788014 |
|
|
Primary Sponsor
|
| Name |
Dr. Prantik Deb |
| Address |
Department of Anaesthesiology and Critical Care, Silchar Medical College and Hospital, Silchar 788014 |
| 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 Prantik Deb |
Silchar Medical College and Hospital |
Department of Surgery, Silchar Medical College and Hospital
Cachar
ASSAM |
8399989633
prantikdeb1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe of Silchar 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 |
| Intervention |
Infusion Dexmedetomidine |
Infusion Dexmedetomidine is given at a doze of 0.5 microgram per kilogram of body weight over a period of 15 minutes before extubation |
| Comparator Agent |
Lignocaine bolus |
Lignocaine bolus is given at a bolus doze of 1.5 miligram per kilogram of body weight just 2 minutes before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-45 years in both sex
ASA grade 1 and 2
Elective abdominal surgeries |
|
| ExclusionCriteria |
| Details |
1. Active upper respiratory infection
2. Known case of drug allergy
3. Patients with respiratory dysfunction and obstructive sleep apnoea
4. Obese patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether dexmedetomidine or lignocaine is more effective in attenuating haemodynamic responses like heart rate , mean arterial pressure, systolic blood pressure and diastolic blood pressure during extubation in abdominal surgeries |
outcomes mentioned above will be measured at 0 mins, 1min, 3 mins, 5 mins, 10 mins, 15 mins , 20 mins , 25 mins and 30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the effects of dexmedetomidine & lignocaine on extubation quality |
to assess the extubation quality score between both the groups from extubation
to every 5 minutues upto 30 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/02/2024 |
| 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="1"
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
|
Extubation of the trachea is the translaryngeal removal of an endotracheal tube from the trachea via the mouth or the nose. It is one of the most uncomfortable stage during general anaesthesia and is almost associated with haemodynamic changes. Extubation during lighter planes of anaesthesia can stimulate reflexes by laryngeal and tracheal stimulation. The laryngopharyngeal stimulationis associated with reflex increase in sympathetic activity leading to haemodynamic changes. These haemodynamic changes are reflected as rise in heart rate and arterial blood pressure and are usually variable. Dexmedetomidine is a centrally acting alpha 2 receptor agonist with sedative and analgesic effect . The sedative-hypnotic and analgesic effect is by an action on alpha 2 receptors in locus ceruleus . Dexmedetomidine can act as a sympatholytic and can attenuate stress respnse to surgery thus maintaining haemodynamic stability. Lignocaine is a synthetic amide - linked local anaesthetic. agent of immediate potency and duration of action. It has a stabilizing effect on cell membrane of cardiac tissue and decreases the automaticity of myocardium by opposing depolarisation of phase 4 action potential spontenously and thus helps in attenuating stress responses to surgeries. |