| CTRI Number |
CTRI/2018/05/013896 [Registered on: 15/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Preventing blood loss in Septoplasty and FESS using Dexmedetomidine or Clonidine premedication |
|
Scientific Title of Study
|
EFFICACY OF I.V CLONIDINE OR DEXMEDETOMIDINE AS PREMEDICATION FOR CONTROLLING BLOOD LOSS IN PATIENTS UNDERGOING SEPTOPLASTY AND FESS UNDER GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mithun B Shetty |
| Designation |
Junior resident |
| Affiliation |
SDM college of medical science and hospital |
| Address |
Dept of Anaesthesiology
SDM college of medical science and hospital
Sattur
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8606342590 |
| Fax |
|
| Email |
mithun.illusion@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Rao |
| Designation |
Head of Department |
| Affiliation |
SDM college of medical science and hospital |
| Address |
Dept of Anaesthesiology
SDM college of medical science and hospital
Sattur
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8762725264 |
| Fax |
|
| Email |
rupprao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mithun B Shetty |
| Designation |
Junior resident |
| Affiliation |
SDM college of medical science and hospital |
| Address |
Dept of Anaesthesiology
SDM college of medical science and hospital
Sattur
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8606342590 |
| Fax |
|
| Email |
mithun.illusion@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical science and hospital |
|
|
Primary Sponsor
|
| Name |
SDM college of medical science and hospital |
| Address |
SDM college of medical science and hospital
Sattur, Dharwad,
Karnataka, India |
| Type of Sponsor |
Private 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 |
| Dr Mithun B Shetty |
SDM college of medical science and hospital |
Dept of anaesthesiology,
OT complex,
2nd floor
Dharwad
KARNATAKA |
8606342590
mithun.illusion@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
Premedication with 1.5 mcg/kg of Clonidine in 100 ml NS over 15 min, 20 minutes prior to induction of general anesthesia |
| Intervention |
Dexmedetomidine |
Premedication with 1 mcg/kg of dexmedetomidine in 100 ml NS over 15 min, 20 min prior induction of general anesthesia |
| Comparator Agent |
Placebo of 100 ml NS |
Placebo of 100 ml NS given over 15 min, 20 minutes prior to induction of general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS 1 or ASA PS 2, undergoing Septoplasty and FESS
2. Willing to participate |
|
| ExclusionCriteria |
| Details |
1. ASA PS >3
2. Basal heart rate < 60 bpm
3. Pregnant women
4. Lactating mother
5. Hepatic, Renal or Cardiac abnormalities
6. Known case of coagulopathy
7. Allergic to Dexmedetomidine or Clonidine
8. Psychiatric disorder or Cognitive delay
9. Active LRTI or cases of Brochial asthma
10. Refusal to participate
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess change in haematocrit during the intraoperative period |
To assess change in haematocrit during the intraoperative period by calculating pre-op, post-op and suction jar Hb/PCV |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Surgical field assessment |
End of surgery |
| Surgeon satisfaction score |
End of surgery |
| Heart rate variability |
Baseline, before & after premedication, prior induction, after intubation, 5,10,15,30,45,60,75,90,105,120,135,150,165,180 minutes after incision |
| Amount of Fentanyl used peri-operatively |
Total usage, calculated at the end of the surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "98"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/10/2017 |
| Date of Study Completion (India) |
15/11/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This is a comoketed study in the above mentioned institute. Statistical analysis is over and the manuscript is ready for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study was conducted in SDM college of medical science and hospital by Dr Mithun B Shetty as a part of his dissertation study and was completed |