| CTRI Number |
CTRI/2020/04/024683 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
22/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two drugs Dexmedetomidine and Propofol for anaesthesia in dental procedures |
|
Scientific Title of Study
|
Dexmedetomidine vs Propofol for conscious sedation in Dental Out Patient Department procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hari Naveen A |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Madhav Nagar,
Manipal
Madhav Nagar,
Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
harinaveen19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandesh U |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Madhav Nagar,
Manipal
Madhav Nagar,
Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
doctor.sandesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandesh U |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College,
Madhav Nagar,
Manipal
Madhav Nagar,
Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
doctor.sandesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Madhav Nagar,
Manipal - 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Madhav nagar,
Manipal-576104 |
| 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 |
| Hari Naveen A |
Kasturba Hospital |
OPD procedure room, Department of Oral Maxillofacial Surgery,
Madhav nagar,
Manipal
Udupi
KARNATAKA |
9940537733
harinaveen19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth, (2) ICD-10 Condition: M274||Other and unspecified cysts of jaw, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug-Dexmedetomidine |
Dexmedetomidine 0.5 to 1.0 µg/kg as a bolus over 10 minutes followed by 0.5 – 1.0 µg/kg/hour as a maintenance dose |
| Comparator Agent |
Propofol |
Propofol 0.5 to 1.0 mg/kg as bolus over 10 mins followed by 5-10 mg/kg/hour as maintenance dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing dental OPD procedures requiring conscious sedation
2. Body Mass Index (BMI) less than 30
3. American Society of Anaesthesiologists (ASA) physical status I or II
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Clinical history or investigative evidence of ischaemic heart disease, impaired liver, renal function
3. Known allergy to Dexmedetomidine, Propofol or fentanyl
4. Body Mass Index (BMI) more than or equal to 30
5. Patients with difficult airway
|
|
|
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 |
| Patient Satisfaction |
Patient Satisfaction using Numerical Rating Scale from 0 to 10 assessed at the end of the procedure once the patient is fully awake |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Awareness during procedure |
Using Modified Brice Questionnaire at the end of the procedure once the patient is fully awake |
| Time taken for discharge |
Using Modified Post Anaesthesia Discharge Scoring System (PADSS) after discontinuation of study drugs at the end of the procedure |
| Episodes of nausea and vomiting |
numerical value by asking the patient at discharge from the hospital |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/05/2020 |
| 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="2"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Conscious sedation with local anaesthesia helps in pain and anxiety relief for dental OPD procedures. Hence we want to compare Dexmedetomidine and Propofol for dental procedures, to assess which drug has better satisfaction rates from patients and a few secondary outcomes such as time taken for discharge, awareness during procedure. |