The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.

Detailed Description
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Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion. Administration of low-dose adrenaline activates the coagulation system and may decrease intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding in elective total hip arthroplasty.

Official Title
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The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial

Conditions
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Intraoperative Blood Loss

Intervention / Treatment
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* Drug: Adrenaline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Scheduled for primary unilateral hip arthroplasty Able to give consent Exclusion Criteria: Allergy towards adrenaline Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5 days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding low molecular weight heparin for perioperative thromboprophylaxis). Current treatment with tricyclic antidepressants Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days). Acute coronary syndrome / myocardial infarction within the previous 6 months. not willing to accept blood transfusion Participation in other clinical trial within previous 30 days Women of childbearing age (without menopause for at least 12 months) Glaucoma Pheochromocytoma Low serum K+ (< 3.0 mmol/L) Thyrotoxicosis Digoxin intoxication Alcohol og drug abuse (investigators judgement)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adrenaline<br>Intraoperative low-dose adrenaline infusion | Drug: Adrenaline<br>* Adrenaline infusion 0.05 microgram / kg / minute<br>* Other names: Ephinephrine;|
| Placebo Comparator: Placebo<br>Placebo: Isotonic Saline | Drug: Placebo<br>* Intraoperative isotonic saline infusion as placebo for adrenaline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | Intraoperative blood loss as estimated from surgical drain and sponges. | End of surgery (last suture) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated blood loss | Calculated blood loss at 24 h after end of surgery. | 24 hours after end of surgery. |