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Comparison of intravenous clonidine vs tranexamic acid for intraoperative blood loss and quality of surgical field during orthognathicsurgery

Phase 4
Not yet recruiting
Conditions
Congenital malformation of face and neck, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,
Registration Number
CTRI/2022/06/043194
Lead Sponsor
Saveetha Dental College and Hospital
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

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
32
Inclusion Criteria
  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.
Exclusion Criteria
    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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intraoperative blood loss- At the end of the surgical procedurePrimary outcome: | Intraoperative blood loss- at the end of the surgical procedure (Day of surgery) | Quality of surgical field- During the surgery (Day of surgery)
Quality of surgical field-During the surgeryPrimary 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 Measures
NameTimeMethod
Drop in hemoglobin levelsMean arterial pressure (MAP)

Trial Locations

Locations (1)

Saveetha Dental College and Hospital

🇮🇳

Chennai, TAMIL NADU, India

Saveetha Dental College and Hospital
🇮🇳Chennai, TAMIL NADU, India
Dr Swetha Bhat
Principal investigator
7204078811
swethavb95@gmail.com

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