"The Effect Of Subcutaneous Epinephrine Dosage On Blood Loss In Surgical Incision"
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Blood loss
研究概览
简要总结
Several studies have attempted to calculate the ideal epinephrine concentration for vasoconstriction, however there has been little consensus. These experiments were carried out on animals, and the degree of vasoconstriction was measured using a variety of methods. Animal studies aren't always reliable since animal capillary density differs from human capillary density. Furthermore, because the density of capillaries in the head and neck is 30 to 40% higher than in other parts of the body, previous studies may not adequately reflect the ideal epinephrine concentration for this highly vascular location. As a result of this study, clinicians will be able to determine the appropriate dose of epinephrine to control intraoperative bleeding. This study aims to determine the effect of different doses of epinephrine on volume of bleeding in surgical incisions in participants undergoing supraclavicular flap surgery.
详细描述
INTRODUCTION The supraclavicular fasciocutaneous flap has recently been described for the repair of pharyngeal, oral cavity, parotid, lateral skull base, and cutaneous defects, among other head and neck deformities.The usage of this flap has been demonstrated to be well tolerated by patients, with low donor site morbidity and good recipient site viability.The supraclavicular flap is fairly thick, has a colour and texture similar to the head and neck area, and has a clear and consistent blood supply. The fap is easy to prepare, and the surgery takes only a few minutes. With the advancement of plastic surgery, the use of the supraclavicular flap is gaining popularity.
Bleeding is one of the most common problems in plastic surgery, and epinephrine injections have long been used to reduce blood loss. Bleeding during surgery can lead to issues such as a drop in haemoglobin, which may necessitate a blood transfusion. Perioperative blood transfusion was found to have an immunosuppressive impact, increasing the risk of infection after surgery. Blood transfusion or mandibular plate rebuilding was similarly associated with severe tissue ablation and a major surgical defect.
Various approaches, such as controlled hypotensive state surgery and infiltration of vasoconstrictive medicines, have been utilized to reduce the quantity of bleeding during the operation. All of these techniques have their own set of difficulties and adverse effects. Vasoconstrictive medications, particularly subcutaneous epinephrine, are now widely utilized to limit bleeding in cosmetic and reconstructive procedures.Due of its potential cardiac and local toxic consequences, ephinephrine has limitations. Arrhythmias, tachycardia, hypertension, and pulmonary edema are all cardiac toxicities that are exacerbated by the administration of hydrocarbon anaesthetics. Delay in healing, lower wound tensile strength, skin necrosis, and higher infection rates are all local toxic consequences.
Because these problems are dose-related, determining the minimum ephinephrine concentration required for adequate hemostasis during head and neck surgery involving supraclavicular flap would vastly improve its margin of safety. To the best of our knowledge, no research has been done on the effect of epinephrine on bleeding in participants undergoing supraventricular flap surgery. However, a study that looked at the impact of varying dosages of epinephrine on the level of vasoconstriction revealed that there were no significant differences in blood flow reduction between epinephrine concentrations of 1:100,000, 1:200,000, and 1:400,000. Epinephrine 1:800,000, on the other hand, caused substantially less vasoconstriction. To achieve optimal initial hemostasis while avoiding potential adverse effects, we recommend administering an epinephrine concentration of 1:200,000 or 1:400,000.
Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age≥ 18 years
- •Patients who are undergoing supraclavicular flap surgery
- •Patients wishing to be a part of study.
- •Either gender
排除标准
- •• Participants with cardio vascular diseases.
- •Participants with collagen vascular diseases
- •Participant who are on non-steroidal anti-inflammatory drugs, anticoagulants, or aspirin. .
研究组 & 干预措施
Epinephrine 1:200,000
In this group participants will receive the epinephrine concentration of 1:200,000 in normal saline
干预措施: Epinephrine injection (Drug)
Epinephrine 1:400,000
In this group participants will receive the epinephrine concentration of 1:400,000 in normal saline
干预措施: Epinephrine injection (Drug)
Placebo
In this group participants will receive only 10 ml of normal saline (control group)
干预措施: Epinephrine injection (Drug)
结局指标
主要结局
Blood loss
时间窗: 5 minutes
Intraoperative blood loss will be measured by direct measuring the volume of blood in the suction bottle
次要结局
未报告次要终点
研究者
Erum Naz
resident of plastic surgery and reconstruction
Dow University of Health Sciences
