| CTRI Number |
CTRI/2018/08/015217 [Registered on: 07/08/2018] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two drugs viz; clonidine and dexmeditomidine for lowering blood pressure in surgical correction of facial bones. |
|
Scientific Title of Study
|
Comparison of efficacy of dexmedetomidine and clonidine infusions to produce hypotensive anaesthesia in patients undergoing orthognathic surgery: a randomized controlled trial-Pilot study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devalina Goswami |
| Designation |
Associate professor |
| Affiliation |
Centre for Dental Education and Research Centre, All India Institute of Medical Sciences, New Delhi |
| Address |
Room 5011, Department of Anaesthesia, Teaching block, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9971196699 |
| Fax |
|
| Email |
drdevalina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Devalina Goswami |
| Designation |
Associate professor |
| Affiliation |
Centre for Dental Education and Research Centre, All India Institute of Medical Sciences, New Delhi |
| Address |
Room 5011, Department of Anaesthesia, Teaching block, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9971196699 |
| Fax |
|
| Email |
drdevalina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devalina Goswami |
| Designation |
Associate professor |
| Affiliation |
Centre for Dental Education and Research Centre, All India Institute of Medical Sciences, New Delhi |
| Address |
Room 5011, Department of Anaesthesia, Teaching block, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9971196699 |
| Fax |
|
| Email |
drdevalina@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New delhi |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
All India Institute of Medical Sciences,Ansari Nagar,New Delhi |
| 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 |
| Devalina Goswami |
operation theatre complex, Centre for Dental Education and Research |
All India Institute For Medical Sciences, Ansari Nagar
New Delhi
DELHI |
9971196699
drdevalina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee, All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Facial deformity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Clonidine |
loading dose of 2-5 μg/kg clonidine over 20 min, followed by 0.3-2 μg/kg/h |
| Comparator Agent |
Intravenouus dexmeditomidine |
loading dose of 1µg/kg dexmedetomidine over 10 min followed by 0.2-0.5µg/kg/h |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anesthesiologists physical status 1
Elective orthognatic surgery
|
|
| ExclusionCriteria |
| Details |
Associated comorbidities
Known allergy or contraindication to the use of any of the drugs
Patients requiring awake intubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraoperative vital parameters ( Heart rate, systolic blood pressure, diastolic blood pessure, mean arterial pressure)
|
every 15 minutes till end of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total amount of study drug required
Total amount of rescue analgesia
Total Blood loss
Need for blood transfusion
Duration of surgery
Quality of surgical field
Adverse effects
|
End of surgery to 6 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/09/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
study not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomised controlled trial to see the efficacy of two anaesthesia drugs, Intavenous clonidine and dexmeditomidine, in its abitity to produce controlled hypotension in patients undergoing orthognatic surgery. The study will be conducted in the Centre for Dental Education and Research, All India Institute of Medical Sciences. Patients of 18 to 60 years age group, belonging to ASA physical status 1 coming for elective orthognatic surgery will be enrolled in the study. Total of 20 patients will be enrolled in the study over a period of 1-2 year ( based on the annual turnover of the centre). Patients will be randomised according to computer generated random numbers. The total amount of each drug used in the intraoperative period will be calculated. Also the amount of rescue analgesia needed, amount of blood loss, quality of surgical field, and any oher adverse events will be noted. Results will be analysed by an independent investigator and appropriate statistical tools applied. |