"The Effect Of Subcutaneous Epinephrine Dosage On Blood Loss In Surgical Incision"

NCT05670808 | Unknown Phase 1 DMC

• 1 other identifier: erumnaz1
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

To Determine the Optimal Doses of Adrenaline in Preventing Blood Loos in Participants Undergoing Supraclavicular Flap Surgery

Keywords

Plastic reconstructive surgery, blood loss, epinephrine, supraclavicular flap

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Intraoperative blood loss will be measured by direct measuring the volume of blood in the suction bottle

  5 minutes

Study Arms (3)

Epinephrine 1:200,000

EXPERIMENTAL

In this group participants will receive the epinephrine concentration of 1:200,000 in normal saline

Drug: Epinephrine injection

Epinephrine 1:400,000

EXPERIMENTAL

In this group participants will receive the epinephrine concentration of 1:400,000 in normal saline

Drug: Epinephrine injection

Placebo

PLACEBO COMPARATOR

In this group participants will receive only 10 ml of normal saline (control group)

Drug: Epinephrine injection

Interventions

Epinephrine injection DRUG

Different doses on epinephrine will be administered to study arms to observe its impact on blood loss

Epinephrine 1:200,000; Epinephrine 1:400,000; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 18 years
• Patients who are undergoing supraclavicular flap surgery
• Patients wishing to be a part of study.
• Either gender

You may not qualify if:

• Participants with cardio vascular diseases.
• Participants with collagen vascular diseases
• Participant who are on non-steroidal anti-inflammatory drugs, anticoagulants, or aspirin. .

Sponsors & Collaborators

• Dow University of Health Sciences: lead

MeSH Terms

Conditions

Hemorrhage

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of plastic surgery and reconstruction

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: January 4, 2023
• Study Start: February 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share