| CTRI Number |
CTRI/2022/10/046459 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
12/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of three commonly used drugs: Dexmedetomidine, Clonidine, and Magnesium Sulphate to find the best drug in reducing blood pressure, blood loss and improved surgical outcome during Sinus Surgery. |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine, Clonidine and Magnesium Sulphate for induced hypotension during functional endoscopic sinus surgery: A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshatha G Kamath |
| Designation |
Post Graduate |
| Affiliation |
St Johns medical college and hospital |
| Address |
Department of Anaesthesiology and critical care,
St Johns Medical College and Hospital,
Sarjapur Road
Koramangala,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
|
| Fax |
|
| Email |
kamathakshatha9596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Rani |
| Designation |
Associate professor |
| Affiliation |
St Johns medical college and hospital |
| Address |
Department of Anaesthesiology and critical care,
St Johns Medical College and Hospital,
Sarjapur Road
Koramangala,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9482903401 |
| Fax |
|
| Email |
rashmidr17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshatha G Kamath |
| Designation |
Post Graduate |
| Affiliation |
St Johns medical college and hospital |
| Address |
Department of Anaesthesiology and critical care,
St Johns Medical College and Hospital,
Sarjapur Road
Koramangala,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
8197431985 |
| Fax |
|
| Email |
kamathakshatha9596@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Akshatha G Kamath |
| Address |
Post Graduate
Department of Anaesthesiology and critical care
St Johns Medical College and Hospital
Sarjapur Road
Koramangala
Bangalore |
| Type of Sponsor |
Other [Self funded] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshatha G Kamath |
St Johns medical college and Hospital |
Department of Anaesthesiology and critical care,
2nd floor,
St Johns medical college and hospital
Sarjapur Road
Koramangala
Bangalore
Bangalore
KARNATAKA |
8197431985
kamathakshatha9596@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SJMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J348||Other specified disorders of noseand nasal sinuses, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injection Clonidine |
Injection clonidine iv 1.5 µg/kg in 50 ml of saline over 20 minutes followed by 0.3-0.5 µg/kg/hour infusion. |
| Intervention |
Injection Dexmedetomidine |
Injection Dexmedetomidine iv 0.75 µg/kg in 50 ml of saline over 20 minutes followed by 0.3-0.5 µg/kg/hour infusion. |
| Comparator Agent |
Injection Magnesium Sulphate |
Injection Magnesium sulphate iv 25mg/kg over 20 minutes followed by an infusion at 5-10 mg/kg/hour. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II physical Status patients |
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable patients
Uncontrolled hypertension/ coronary artery disease/ Heart blocks/ Autonomic neuropathy/ Renal dysfunction/ Hepatic dysfunction/ Cerebral insufficiency
Patients allergic to the drugs being studied
Patients with coagulopathy, bleeding disorders, platelet dysfunction
Patients with vascular/congenital anomalies of nasal mucosa
Pregnancy
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Dexmedetomidine, Clonidine and Magnesium Sulphate in inducing controlled hypotension |
Measured at baseline, after the loading dose, after induction, 1 minute after intubation, 5 minutes after intubation and thereafter every 10 minutes until shifting of the patient to the recovery area. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Calculating the estimated blood loss |
Measured every 30 Minutes |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
20/10/2022 |
| 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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a double blinded, randomized control trial to compare Dexmedetomidine 0.75 µg/kg in 50 ml of saline over 20 minutes followed by 0.3-0.5 µg/kg/hour infusion, Clonidine 1.5 µg/kg in 50 ml of saline over 20 minutes followed by 0.3-0.5 µg/kg/hour infusion and Magnesium sulphate 25mg/kg over 20 minutes followed by an infusion at 5-10 mg/kg/hour for induced hypotension during functional endoscopic sinus surgery in patients belonging to ASA I and II physical status in St John’s medical College and Hospital, Bengaluru. Primary outcome will be comparing the efficacy of these drugs in inducing controlled hypotension. The secondary outcome will be assessing and comparing the improved surgical field visibility, analgesia and post-operative recovery with the use of these drugs. This study is proposed to compare the efficacy of the three drugs in producing hypotension. Comparison of the three drugs and the resultant evidence may also help in identifying the drug that is more efficacious as well as cost effective.
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