The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
- Registration Number
- NCT01708642
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- Age > 18 years.
- Scheduled for primary unilateral hip arthroplasty
- Able to give consent
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo: Isotonic Saline Adrenaline Adrenaline Intraoperative low-dose adrenaline infusion
- Primary Outcome Measures
Name Time Method Intraoperative blood loss End of surgery (last suture) Intraoperative blood loss as estimated from surgical drain and sponges.
- Secondary Outcome Measures
Name Time Method Calculated blood loss 24 hours after end of surgery. Calculated blood loss at 24 h after end of surgery.
Trial Locations
- Locations (3)
Hvidovre Hospital, Department of orthopaedic surgery
🇩🇰Hvidovre, Denmark
Vejle Sygehus, Department of orthopedic surgery
🇩🇰Vejle, Denmark
Gentofte Hospital, Department of Anaesthesia
🇩🇰Hellerup, Denmark