| CTRI Number |
CTRI/2021/07/034551 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
30/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare three maintenance doses of Dexmedetomidine for intravenous sedation in third molar extraction surgery |
|
Scientific Title of Study
|
A comparative clinical trial comparing three maintenance doses of Dexmedetomidine for intravenous sedation in third molar extraction surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Batra |
| Designation |
Principal cum Professor and Head of Department, Oral and maxillofacial Surgery |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Dr. Hemant Batra, Principal cum Professor , head of department , Department of oral and Maxillofacial surgery , Dr. harvansh Singh Judge Institute of Dental sciences, Panjab University , Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9814555550 |
| Fax |
|
| Email |
hemant_batra69@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Batra |
| Designation |
Principal cum Professor and Head of Department, Oral and maxillofacial Surgery |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Dr. Hemant Batra, Principal cum Professor , head of department , Department of oral and Maxillofacial surgery , Dr. harvansh Singh Judge Institute of Dental sciences, Panjab University , Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9814555550 |
| Fax |
|
| Email |
hemant_batra69@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Batra |
| Designation |
Principal cum Professor and Head of Department, Oral and maxillofacial Surgery |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Dr. Hemant Batra, Principal cum Professor , head of department , Department of oral and Maxillofacial surgery , Dr. harvansh Singh Judge Institute of Dental sciences, Panjab University , Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9814555550 |
| Fax |
|
| Email |
hemant_batra69@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dept of Oral and Maxillofacial Surgery
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital, PU |
|
|
Primary Sponsor
|
| Name |
Dr Harsimran Kaur |
| Address |
Room no 5
Dept of Oral and Maxillofacial Surgery
Dr. Harvansh Singh Judge Institute of dental sciences and hospital, Sector 25 , Panjab University , Chandigarh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhavya Mishra |
Room no 5
Dept of Oral and Maxillofacial Surgery
Dr. Harvansh Singh Judge Institute of dental sciences and hospital, Sector 25 , Panjab University , Chandigarh |
| Dr Hemant Batra |
Room no 5
Dept of Oral and Maxillofacial Surgery
Dr. Harvansh Singh Judge Institute of dental sciences and hospital, Sector 25 , Panjab University , Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsimran Kaur |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital |
Department of Oral and Maxillofacial Surgery,
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital,Sector 25 , Panjab University
Chandigarh
CHANDIGARH |
9888240333
sim820@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Degree Committee, Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital, Panjab University, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Loading dose 1mcg/kg over 10 minutes and maintenence dose of 0.2 mcg/ Kg/ hr |
| Intervention |
Dexmedetomidine |
Loading dose 1mcg/kg over 10 minutes and maintenence dose of 0.2 mcg/ Kg/ hr |
| Comparator Agent |
Dexmedetomidine |
Loading dose 1mcg/kg over 10 minutes and maintenence dose of 0.4 mcg/ Kg/ hr |
| Intervention |
Dexmedetomidine |
Loading dose 1mcg/kg over 10 minutes and maintenence dose of 0.4 mcg/ Kg/ hr |
| Comparator Agent |
Dexmedetomidine |
Loading dose 1mcg/kg over 10 minutes and maintenence dose of 0.6 mcg/ Kg/ hr |
| Comparator Agent |
Dexmedetomidine |
Loading dose 1mcg/kg over 10 minutes and maintenence dose of 0.6 mcg/ Kg/ hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 patient
Patient requiring 3rd molar extraction surgery under LA
Patient willing for intravenous sedation during the procedure
|
|
| ExclusionCriteria |
| Details |
Pregnant females
Lactating mothers.
Patient with history of drug allergy to any drug.
Patient on any medication
History of dental treatment phobia
Abnormal gag reflex
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objectives: to compare the following parameters:
1. Sedation scores
2. Pain scores
3. Hemodynamic and respiratory effects
4. Time of discharge of patient
Secondary objectives: to compare the following parameters:
1. Amnesia
2. Surgeon satisfaction score
3. Patient satisfaction score
4. Duration of analgesia
5. Requirement of rescue sedation
6. Any other side effects noted during the procedure
|
Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2 and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved.
VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes.
PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Amnesia
2. Surgeon satisfaction score
3. Patient satisfaction score
4. Duration of analgesia
5. Requirement of rescue sedation
6. Any other side effects noted during the procedure |
1. Amnesia- The patient will be asked to recall a pin prick given after 20 minutes of procedure post operatively
2. Surgeon satisfaction score: noted post operatively
3. Patient satisfaction score: noted post operatively
4. Duration of Analgesia- noted postoperatively
5. Requirement of rescue sedation with 1 mg intravenous Midazolam if Ramsay sedation score is 1 during the procedure
6. Any other side effects in the intraoperative or postoperative period will be noted |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
05/07/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - The scientific journal in which the study will be published in future.
- For how long will this data be available start date provided 05-07-2022 and end date provided 05-07-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In the present study we aim to evaluate and compare different parameters in three groups of patients receiving different maintenance doses of dexmedetomidine during third molar extraction surgery and to determine the ideal maintenance dose of Dex suitable for sedation with minimal side effects and early discharge from the OPD of the Department of Oral and Maxillofacial Surgery , Dr. HSJ Institute of Dental Sciences, Chandigarh. The three maintenance doses of Dexmedetomidine (0.2, 0.4 and 0.6 mcg/kg/hr) shall be compared for their hemodynamic and respiratory effects; onset and time of sedation (achieving a Ramsay score of ≥2 and Ramsay score of ≤2 after the procedure, respectively); Ramsay sedation scores during the procedure; recovery and discharge time.
|