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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01708642

Enrollment

106

Registered

2012-10-17

Start date

2012-11-30

Completion date

2013-09-30

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Blood Loss

Brief summary

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

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.

Interventions

DRUGAdrenaline

Adrenaline infusion 0.05 microgram / kg / minute

DRUGPlacebo

Intraoperative isotonic saline infusion as placebo for adrenaline.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Calculated blood loss	24 hours after end of surgery.	Calculated blood loss at 24 h after end of surgery.

Other

Measure	Time frame	Description
Drug side effects	During surgery (from start of procedure to last suture)	Side effects causing discontinuation the study drug.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026