| CTRI Number |
CTRI/2019/03/018007 [Registered on: 08/03/2019] Trial Registered Prospectively |
| Last Modified On: |
07/03/2019 |
| 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 study to compare the how good is dexmedetomidine and labetalol for providing reduced blood pressure during anaesthesia for surgeries of ear, nose and throat. |
|
Scientific Title of Study
|
A randomized control trial to compare the efficacy of dexmedetomidine and labetalol for induced hypotensive anaesthesia in ear, nose and throat surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Robin Sajan Chacko |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9496140000 |
| Fax |
|
| Email |
robinsajan@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Krishnagopal |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram 503108
Tamil Nadu India
Shri Sathya Sai Medical College and Research Institute
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
984155756 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Robin Sajan Chacko |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9496140000 |
| Fax |
|
| Email |
robinsajan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram 503108
Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
Robin Sajan Chacko |
| Address |
KBC Enclave,
Laikkad, Perunna PO,
Changanacherry,
Kottayam 686102,
Kerala, 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 |
| Robin Sajan Chacko |
Shri Sathya Sai Medical College and Research Institute |
ENT OT number 5
Second Floor OT Complex
Shri Sathya Sai Medical College and Research Institute,
Thiruporur Guduvanchery Main Road,
Ammapettai Nellikuppam,
Kancheepuram 603108
Kancheepuram
TAMIL NADU |
9496140000
robinsajan@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, (2) ICD-10 Condition: H952||Intraoperative hemorrhage and hematoma of ear and mastoid process complicating a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Loading infusion of 1mcg/kg over 10 minutes followed by maintenance infusion of 0.4mcg/kg/hr for producing controlled hypotension during general anaesthesia |
| Intervention |
Labetalol |
Loading Infusion of 0.25mg/kg over 10 minutes followed by maintenance infusion of 30mg/hr for producing controlled hypotension during general anaesthesia |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex undergoing elective ENT surgeries under general anaesthesia
2. American Society of Anaesthesiologists I or II
3. BMI between 18.5 and 24.9 kg/m2 |
|
| ExclusionCriteria |
| Details |
1. American Society of Anaesthesiologists III and above
2. Allergic to study drugs.
3. Asthmatic patients.
4. Patients having coagulopathy.
5. Patients with heart blocks.
6. Lactating mothers and pregnant patients.
7. Hepatic or renal abnormality.
8. Patients with congestive cardiac failure, bradycardia.
9. Hypertensive patients.
10. Patients using beta blockers. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline. |
Intraoperative Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare surgeon’s satisfaction of surgical field between the study drugs. |
Intraoperative period |
| To compare total blood loss occurring during surgery between the study drugs. |
Intraoperative period |
| To compare recovery time between the study drugs. |
Postoperative period |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
12/03/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a randomized controlled trial to compare the efficacy of dexmedetomidine and labetalol for producing induced hypotensive anaesthesia in 58 patients posted for ear nose throat surgeries over a period of 18 months. The primary outcome would be to compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline. The secondary objectives are to compare surgeon’s satisfaction of surgical field between the study drugs, to compare total blood loss occurring during surgery between the study drugs and to compare recovery time between the study drugs. |