| CTRI Number |
CTRI/2025/07/090580 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
The study is to evaluate a drug called Dexmedetomidine in reducing stress and anxiety levels for patients who are afraid of undergoing surgical extraction of lower impacted third molars. |
|
Scientific Title of Study
|
Evaluation of Anxiolytic and Analgesic effect of Intranasal spray of Dexmedetomidine in patients undergoing surgical removal of impacted mandibular third molar: A Randomised Clinical Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupinder Kaur |
| Designation |
post graduate student |
| Affiliation |
KAHER KLE VKIDS Belagavi |
| Address |
Department of Oral and Maxillofacial Surgery
KAHER KLE VKIDS
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8146245659 |
| Fax |
|
| Email |
kaur43075@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay S RAo |
| Designation |
professor and head of the department |
| Affiliation |
KAHER KLE VKIDS Belagavi |
| Address |
Department of Oral and Maxillofacial Surgery
KAHER KLE VKIDS
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845454266 |
| Fax |
|
| Email |
sanjsamuel@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupinder Kaur |
| Designation |
post graduate student |
| Affiliation |
KAHER KLE VKIDS Belagavi |
| Address |
Department of Oral and Maxillofacial Surgery
KAHER KLE VKIDS
Belagavi
KARNATAKA
590010
India |
| Phone |
8146245659 |
| Fax |
|
| Email |
kaur43075@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery
KAHER KLE VKIDS
Belagavi
India
590010 |
|
|
Primary Sponsor
|
| Name |
Rupinder Kaur |
| Address |
Department of Oral and Maxillofacial Surgery
KAHER KLE VKIDS
Gangambika ladies resident hostel
JNMC CAMPUS
Belagavi
India
590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rupinder Kaur |
KAHER KLE VKIDS |
Department of Oral and Maxillofacial Surgery
Belgaum
KARNATAKA |
8146245659
kaur43075@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
impacted. mandibular third molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
reduces the anxiety level in patient before undergoing surgery.
dose= 0.7mcg/kg given intranasal
administered only once before the procedure according to patients weight. |
| Comparator Agent |
normal saline |
used for placebo.
2.5 ml of 0.9%saline
administered only once before the procedure given intranasal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give informed consent
Patients who are anxious
ASA class I patients
Patients who on evaluation have moderate surgical difficulty score on Pederson index |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate
Patients with systemic illness
Patients already on longterm sedatives or analgesic use
Patients with acute rhinitis upper respiratory tract infection cvs diseases and allergy to dexmedetomidine
Pregnant or lactating females |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in anxiety and stress levels |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in anxiety and stress levels |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
|
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
|
The study aims to assess anxiety levels before and after administration of intranasal spray of Dexmedetomidine which is a mild sedative and is effective for relaxation stress management and post operative analgesia as well. Dexmedetomidine is a centrally acting selective alfa 2 adrenoreceptor agonist and is a tasteless and odourless drug. |