| CTRI Number |
CTRI/2025/06/088785 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Comparison Of Dexmedetomidine And Lignocaine In Managing The Intraocular Pressure And Heamodynamic Changes Post Suxamethonium Administration, Laryngoscopy, And Tracheal Intubation In Cancer Surgeries. |
|
Scientific Title of Study
|
A Comparitive Evaluation Of Intravenous Dexmedetomidine And Intravenous Lignocaine In Attenuating The Rise In Intraocular Pressure And Heamodynamic Response Following Administration Of Suxamethonium, Laryngoscopy And Endotracheal Intubation In Oncological Surgeries. |
| Trial Acronym |
IOP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjana Vinod |
| Designation |
Postgraduate Resident |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room 5, Kidwai Postgraduate Womens hostel, Kidwai Memorial Institute of Oncology, MH Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9591434171 |
| Fax |
|
| Email |
anjuvinx@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Ranganath |
| Designation |
Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room 105, OT Block, Ground Floor, Kidwai Memorial Institute of Oncology, MH Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9880642830 |
| Fax |
|
| Email |
namrang@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Ranganath |
| Designation |
Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room 105, OT Block, Ground Floor, Kidwai Memorial Institute of Oncology, MH Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9880642830 |
| Fax |
|
| Email |
namrang@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute Of Oncology,MH Marigowda Road,Hombegowda Nagar, Bangalore, Karnataka,India -560029 |
|
|
Primary Sponsor
|
| Name |
Dr. Anjana Vinod |
| Address |
Room 5, Kidwai Postgraduate Womens hostel, Kidwai Memorial Institute of Oncology, MH Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru |
| 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 Anjana Vinod |
Kidwai Memorial Institute of Oncology |
Department of Anesthesiology and Pain Relief, OT Block, Kidwai Memorial Institute of Oncology, MH Marigowda Rd, Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA |
9591434171
anjuvinx@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE,KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
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 |
Dexmedetomidine injection |
Patients will receive 0.5mcg/kg IV dexmedetomidine in 10 ml sterile water, over 10 min prior to induction |
| Comparator Agent |
Lignocaine injection |
Patients will receive 1.5mg/kg of IV lignocaine,2 min prior to induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 65 years.
(and)
Patients belonging to ASA physical status grade 1 and 2.
(and)
Patients consenting for study. |
|
| ExclusionCriteria |
| Details |
Patient’s refusal (or)
Patients with severe cardiac, respiratory and renal disease. (or)
Patients with known neurological disorder. (or)
Patients with preexisting ocular diseases or history of eye surgery. (or)
Pregnant or breastfeeding females. (or)
Known allergy or contraindications to either lignocaine or dexmedetomidine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of intravenous dexmedetomidine and intravenous lignocaine for attenuating IOP and hemodynamic response after suxamethonium administration, laryngoscopy and intubation |
Baseline values, pre-induction, post-induction (1 minute, 3 minutes, 5 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any adverse effects of intravenous dexmedetomidine and intravenous lignocaine |
Intra-operative and post-operative period (upto 24 hours) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="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
|
This randomized prospective comparitive study aims to compare the effectiveness of intravenous Dexmedetomidine (group-D) 0.5mcg/kg and intravenous Lignocaine (group-L) 1.5mg/kg in attenuating rise in IOP as an indicator of attenuating hemodynamic response following administration of suxamethonium laryngoscopy and intubation in ASA I and ASA II patients undergoing elective oncological surgeries under general anesthesia. The baseline values, pre-induction, post-induction (1 min, 3 mins and 5 mins) of intra-ocular pressure(IOP), non-invasive blood pressure(NIBP), mean arterial pressure(MAP), and heart rate(HR) are measured and compared in both the groups.
Adverse effects such as Hypotension, Bradycardia, Arrythmias, etc in either groups will also be noted. During the whole perioperative period heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation and ECG will be monitored and documented as per standard protocol and patient will be shifted to ICU for further monitoring.
|
|