| CTRI Number |
CTRI/2022/06/043194 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
08/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of intravenous clonidine vs tranexamic acid for intraoperative blood loss and quality of surgical field during orthognathic
surgery |
|
Scientific Title of Study
|
Comparing the effectiveness of intravenous clonidine and tranexamic acid on
intraoperative blood loss and quality of surgical field during orthognathic
surgery-a randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swetha Bhat |
| Designation |
Post graduate |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha Dental
College and Hospital, Poonamallee High Road, Velappanchavadi,
Chennai, Tamil Nadu
Department of Oral and Maxillofacial Surgery, Saveetha Dental
College and Hospital, Poonamallee High Road, Velappanchavadi,
Chennai, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
7204078811 |
| Fax |
|
| Email |
swethavb95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Senthilnathan Periasamy |
| Designation |
Proffessor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha Dental
College and Hospital, Poonamallee High Road, Velappanchavadi,
Chennai, Tamil Nadu
Department of Oral and Maxillofacial Surgery, Saveetha Dental
College and Hospital, Poonamallee High Road, Velappanchavadi,
Chennai, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
7204078811 |
| Fax |
|
| Email |
151904006.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Swetha Bhat |
| Designation |
Post graduate |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha Dental
College and Hospital, Poonamallee High Road, Velappanchavadi,
Chennai, Tamil Nadu
Department of Oral and Maxillofacial Surgery, Saveetha Dental
College and Hospital, Poonamallee High Road, Velappanchavadi,
Chennai, Tamil Nadu
TAMIL NADU
600077
India |
| Phone |
7204078811 |
| Fax |
|
| Email |
swethavb95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital, 162, Poonamallee high rd, Velappanchavadi, Chennai, Tamil Nadu 77 |
| Shapoorji PallonjiInfrastructure Capital Co Pvt Ltd, OM Nagar-2, panchavati society, Rabadia colony, Kodinar, Gujarat 362720 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospital |
| Address |
Saveetha Dental College and Hospital, Poonamallee High Road,
Velappanchavadi, Chennai, Tamil Nadu 600077
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shapoorji PallonjiInfrastructure Capital Co Pvt Ltd |
OM Nagar-2, Panchavati Society, Rabadia Colony, KOdinar-362720, Gir Somnath, Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swetha Bhat |
Saveetha Dental College and Hospital |
Department of Oral and
Maxillofacial Surgery,
Saveetha Dental
College and Hospital,
Poonamallee High
Road,
Velappanchavadi,
Chennai, Tamil Nadu
600077
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
7204078811
swethavb95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q189||Congenital malformation of face and neck, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Clonidine |
Inj clonidine 3microgram/ kg
To be administered half an hour before the start of the surgical procedure
Total duration of the intervention- time from the beginning to the end of the surgical procedure |
| Comparator Agent |
Intravenous Tranexamic acid |
Inj Tranexamic acid 20 mg/kg
To be administered half an hour before the start of the surgical procedure
Total duration of the intervention- time from the beginning to the end of the surgical procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age 18-40years of age
2)Patients in American Society of Anaesthesiology
Classification I and II
3) Patient who were candidates for orthognathic
surgery |
|
| ExclusionCriteria |
| Details |
1) History of systemic disease, coagulopathy,
bleeding disorder, vascular anomaly, recent
anticoagulant therapy.
2)Patients with bone disease (eg. Fibrous dysplasia)
3) Cleft lip and palate
4) Patients to receive simultaneous temporo-
mandibular joint surgery or bone graft harvest |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraoperative blood loss- At the end of the surgical procedure
Quality of surgical field-During the surgery
|
Primary outcome:
Intraoperative blood loss- at the end of the surgical procedure (Day of surgery)
Quality of surgical field- During the surgery (Day of surgery)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Drop in hemoglobin levels
Mean arterial pressure (MAP)
Operating time |
Drop in hemoglobin levels- After 24 hours
Mean arterial pressure- intraoperatively on the day of surgery
Operating time- By the end of the surgery (on day of surgery) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/06/2022 |
| 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
|
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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- 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 - Proposals should be directed to [swethavb95@gmail.com].
- For how long will this data be available start date provided 15-07-2022 and end date provided 15-07-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Orthognathic surgery is a well-established method to correct various forms of dentofacial deformity. As the orofacial region is very vascular, significant blood loss can occur and a subsequent need for blood transfusion is often encountered. A surgical site with the least bloodshed possible contributes to decreased surgical time, better visualization of the surgical field, and increased quality of the surgery. Use of single intravenous preoperative dose of Tranexamic acid and Clonidine was effective in preventing excessive postoperative bleeding. Better agent among these two drugs has not yet been identified. This study aims to compare the efficacy of intranvenous clonidine and tranexamic acid as a premedication to control intraoperative blood loss and producing a better surgical field during orthognathic surgery
Sample size- 32
Groups: Group 1: 16 (Intravenous Clonidine) Group 2: 16 (Intravenous Tranexamic acid)
Primary outcome: 1) Intraoperative blood loss 2) Quality of surgical field Secondary outcomes: 1) Drop in hemoglobin levels 2) Mean arterial pressure (MAP) 3) Operating time |