| CTRI Number |
CTRI/2025/04/084031 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY TO COMPARE THE EFFICACY OF TWO DIFFERENT DOSES OF DEXMEDETOMIDINE ON BLOOD PRESSURE AND HEART RATE DURING LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN PATIENT UNDERGOING LAPROSCOPIC SURGERY UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF TWO DIFFERENT DOSES OF DEXMEDETOMIDINE ON HEMODYNAMIC RESPONSE DURING DL AND EI IN PATIENT UNDERGOING LAPROSCOPIC SURGERY UNDER GA. A RANDOMIZED CONTROLLED 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 |
Hariharan V |
| Designation |
Post graduate Trainee |
| Affiliation |
ESIC Medical college and hospital |
| Address |
3rd floor ,Room. No 301 Department of Anaesthesiology, Esic medical college and hospital, joka,kolkata
Kolkata
WEST BENGAL
700104
India |
| Phone |
9585660078 |
| Fax |
|
| Email |
v.hariharan1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.ANIL KUMAR THAKUR |
| Designation |
HOD and PROFESSOR |
| Affiliation |
ESIC Medical college and hospital |
| Address |
Room no.302, Department of Anaesthesia, Esic medical college and hospital, joka,kolkata
Kolkata
WEST BENGAL
700104
India |
| Phone |
9350103337 |
| Fax |
|
| Email |
dranilthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hariharan V |
| Designation |
Post graduate Trainee |
| Affiliation |
ESIC Medical college and hospital |
| Address |
Room no 303 Department of Anaesthesia, Esic medical college and hospital,,joka,kolkata
Kolkata
WEST BENGAL
700104
India |
| Phone |
9585660078 |
| Fax |
|
| Email |
v.hariharan1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
ESI-PGIMSR, ESIC Medical college,Diamond Harbour Rd, Bratachari Gram, Joka, Kolkata, West Bengal 700104 |
|
|
Primary Sponsor
|
| Name |
ESIPGIMSR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Esic medical college and hospital,Diamond Harbour Rd, Bratachari Gram, Joka, Kolkata, West Bengal 700104 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Hariharan |
Esi-pgimsr, esic medical college and hospital |
3rd floor ot complex, Department of Anaesthesiology, esic medical college and hospital, joka
South Twentyfour Parganas
WEST BENGAL |
9585660078
v.hariharan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Employeess state insurance corporation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomedine 0.75mcg/kg |
It is the drug approved for ICU sedation and to control pressor response |
| Comparator Agent |
Dexmedetomidine 1mcg/kg |
Dexmedetomidine is the drug approved for ICU sedation and to reduce pressor response |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 to 60 years of age
ASA physical status 1 and 2
with airway Mallampati Grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
Refusal
pregnant patient
on beta blockers
morbid patients
Full stomach
on alpha 2 agonist
patient suffering from heartblock or sicksinus syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IV Dexmedetomidine 1 mcg/kg is more effective than intravenous Dexmedetomidine 0.75mcg in suppressing pressor response during laryngoscopy and intubation in patients undergoing laparoscopic surgery. |
Preparatory phase- 2 month
Phase of data collection- 08 months
Phase of data analysis- 02 months
d. Report writing & submission- 02 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of two different doses of Dexmedetomidine on hemodynamic response during direct laryngoscopy & endotracheal intubation in patient undergoing laparoscopic surgery under general anaesthesia |
Hemodynamic parameters like the Heart rate systolic & diastolic blood pressure & mean arterial pressure will be measured 15 minutes after drug administration & 1 min 3mins 5mins 10mins 15mins post intubation |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
17/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Secure airway for proper ventilation during anaesthesia is one of the most important component of a successful surgery . Many drugs are used to reduce the hemodynamic stress response during laryngoscopy and endotracheal intubation. The question for ideal drugs and their dosage without major side effects is still pursued . This research aimed to investigate the impact of two different doses of Dexmedetomidine in mitigating the stress response during laryngoscopy and endotracheal intubation. Dexmedetomidine is an alpha-2 receptor agonist and shorter acting than clonidine, is emerging as a promising drug to counteract the catecholamine release. |