| CTRI Number |
CTRI/2022/06/043057 [Registered on: 07/06/2022] Trial Registered Prospectively |
| Last Modified On: |
03/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare duration of pain relief between dexmedetomidine or clonidine in combination with lignocaine with adrenaline in local anaesthesia in tympanoplasty |
|
Scientific Title of Study
|
Comparison of dexmedetomidine and clonidine as an adjuvant to lignocaine with adrenaline in infiltration anaesthesia in tympanoplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonam Mittal |
| Designation |
Post graduate resident |
| Affiliation |
JLN medical college Ajmer |
| Address |
Department of anaesthesiology
New OT JLN medical college Ajmer AJMER
RAJASTHAN
INDIA
Ajmer
RAJASTHAN
305001
India |
| Phone |
9772006847 |
| Fax |
|
| Email |
mittalsonam291@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college Ajmer |
| Address |
Department of anaesthesiology
New OT JLN medical college Ajmer AJMER
RAJASTHAN
INDIA
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college Ajmer |
| Address |
Department of anaesthesiology
New OT JLN medical college Ajmer AJMER
RAJASTHAN
INDIA
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN MEDICAL COLLEGE AJMER |
|
|
Primary Sponsor
|
| Name |
JLN medical college Ajmer |
| Address |
Department of anaesthesiology,JLN medical college Ajmer,Rajasthan |
| 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 |
| Dr Sonam Mittal |
JLN medical college |
ENT OT , Department of Anaesthesiology
JLN Medical College.
Ajmer
RAJASTHAN |
9772006847
mittalsonam291@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H728||Other perforations of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine with Lignocaine and adrenaline |
Post auricular region and four quadrants of external auditory canal are locally infiltreted with 12 ml of lignocaine 2% with 1 in 200000 adrenaline plus inj clonidine 1 mcg /kg Edit || Delete
|
| Intervention |
Dexmedetomidine with lignocaine and Adrenaline |
Post auricular region and four quadrants of external auditory canal are locally infiltreted with 12 ml of lignocaine 2% with 1 in 200000 adrenaline plus inj Dexmeditomedine 1 mcg /kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) age group 18-60 years.
2) body weight 40-60 kg.
3)patient belonging to ASA(American society of anaesthesiology) class 1 and 2.
4)patient undergoing elective tympanoplasty under local anaesthesia.
5)duration of surgery 60 mins. |
|
| ExclusionCriteria |
| Details |
1) Age < 18 years and > 60 years.
2) ASA grade III and above.
3) Patients allergic to study drugs.
4) History of use of any opioids or sedative medications in the week prior to surgery
5) Patients on psychotropic drug.
6)Pregnant and lactating females.
7)Patients with cardiovascular disease and congenital disorders.
8)Significant systemic disorders.
9) Patient with history of seizure disorders
10)Patient refusal to take part in study
11) Obese patients with BMI more > 28 kg/m2
. |
|
|
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 |
| comparison of duration of analgesia in both the group for 24 hours |
comparison of onset of analgesia ( in seconds) and duration of analgesia during total duration of surgery and for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the hemodynamic changes.
bleeding at the site of surgery.
patient and surgeon satisfaction.
|
around 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/06/2022 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
The aim of study is to assess and compare dexmedetomedine and clonidine in patients posted for elective tympanoplasty under local anaesthesia with respect to duration of analgesia ,hemodynamic changes,bleeding at the site of surgery and patient and surgeons satisfaction. |