Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
NCT06085976 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2023-10-17
Summary
The goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases.
The main questions it aims to answer are:
* Decrease in intraoperative bleeding measured in ml of blood lost.
* Decrease in the need for blood transfusion and use of intraoperative vasoactive drugs.
Participants will receive octreotide or placebo after signing the informed consent form.
Conditions
- Hepatic Carcinoma
- Hepatic Metastasis
Interventions
- DRUG
-
Octreotide
A loading dose of 100 mcgr of octreotide will be administered in the intervention group, diluted in 100 ml of SSF to be passed in 30 minutes. Subsequently, it will be administered in continuous perfusion at 25 mcgr/h in the intervention group. The drug can be administered through a peripheral or central venous line at the choice of the anesthesiologist, since the drug has a density that allows its administration by both routes.
- OTHER
-
Placebo
In the case of the control group, 100 ml of SSF will be administered to be passed in half an hour and then an perfusion of SSF.
Sponsors & Collaborators
-
Clinica Universidad de Navarra, Universidad de Navarra
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-14
- Primary Completion
- 2025-08-14
- Completion
- 2025-11-30
Countries
- Spain
Study Locations
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