In short
This article provides information about 2 ongoing clinical trials related to metabolic surgery. These studies focus on improving safety and pain management for patients undergoing weight-loss surgery, particularly those with obesity and related conditions. The trials are being conducted in Denmark and the Netherlands, investigating medications to reduce bleeding and improve pain relief during and after surgical procedures.
Clinical trial locations
- Denmark
- Netherlands
Study on Morphine, Lidocaine, and Naloxone for Patients with Obesity and Sleep Apnea
This clinical trial is investigating how the body processes and responds to morphine hydrochloride, a medication commonly used for pain relief, particularly in patients with obesity and obstructive sleep apnea undergoing surgery. The study aims to develop more personalized pain management strategies for these patients, ensuring effective pain relief with minimal side effects.
Who can participate:
- Adults aged 18 years and older
- Individuals with obesity
- People with obstructive sleep apnea, a condition where breathing stops and starts during sleep
- Both men and women are eligible
- Those able to give informed consent and participate without additional risks
Who cannot participate:
- People who do not have obesity or obstructive sleep apnea
- Those not undergoing bariatric surgery, which is a type of weight-loss surgery
- Individuals outside the specified age range
- Members of vulnerable populations who may be at higher risk of harm or exploitation
What the study involves:
The study focuses on understanding how morphine works in the body of patients with these specific conditions. Participants will receive morphine through injections, and researchers will closely monitor how it is absorbed and how it affects the body. The study also involves the use of naloxone hydrochloride, an antidote for morphine, and lidocaine hydrochloride, a local anesthetic, to better understand their roles in managing pain and potential side effects.
Throughout the study, participants undergo various assessments including baseline measurements, medication administration under medical supervision, and regular monitoring for side effects. Quantitative sensory testing is performed to evaluate responses to different stimuli such as heat, cold, and pressure. The study is expected to conclude by January 31, 2025.
Investigational drug:
Morphine is the primary medication being studied. It works by changing the way the brain and nervous system respond to pain, binding to opioid receptors in the brain to block pain sensations. This trial aims to determine how to use morphine safely and effectively for surgical pain relief in patients with obesity and sleep apnea, helping doctors provide better, personalized pain management.
Study on Tranexamic Acid and Sodium Chloride to Reduce Bleeding in Gastric Bypass Surgery for Patients with Severe Obesity
This clinical trial is studying whether tranexamic acid can help reduce bleeding in patients with morbid obesity who are undergoing gastric bypass surgery, a type of weight-loss procedure. The study compares patients who receive tranexamic acid with those who receive a placebo to determine if there is a difference in the amount of bleeding during and after surgery.
Who can participate:
- Adults at least 18 years old
- People eligible for bariatric surgery according to specific guidelines
- Those undergoing laparoscopic gastric bypass surgery, specifically Roux-en-Y or one-anastomosis procedures
- Both men and women can participate
Who cannot participate:
- Patients who do not have morbid obesity
- Those outside the specified age range for the study
- Members of vulnerable populations, such as children or those unable to make decisions for themselves
What the study involves:
The study focuses on patients undergoing minimally invasive gastric bypass surgery. During the operation, tranexamic acid is administered intravenously to help manage blood loss. After surgery, careful monitoring identifies any bleeding complications, such as the need for additional interventions or blood transfusions. Researchers also track blood loss, changes in hemoglobin levels, heart rate, and any signs of bleeding.
The study evaluates the effectiveness of the medication in reducing bleeding by assessing the need for further interventions and overall blood loss during and after surgery. Secondary outcomes include the use of additional hemostatic devices, the duration of surgery, and any side effects from the medication. The estimated completion date for this study is December 1, 2025.
Investigational drug:
Tranexamic Acid (TXA) is the medication being investigated. It works by preventing the breakdown of blood clots, which helps control bleeding during and after surgical operations. This antifibrinolytic agent is being studied to determine whether it can lower the risk of excessive bleeding in patients undergoing gastric bypass procedures, potentially improving surgical safety for those with severe obesity.
Summary
Two clinical trials are currently ongoing in the field of metabolic surgery, with one trial in Denmark and one in the Netherlands. Both studies focus on improving safety and outcomes for patients undergoing weight-loss surgery, though they address different aspects of surgical care.
The Danish trial concentrates on pain management, specifically investigating how morphine behaves in patients with obesity and obstructive sleep apnea. This research aims to personalize pain relief strategies for surgical patients with these conditions, ensuring effective treatment with minimal side effects.
The Netherlands trial focuses on surgical safety by studying whether tranexamic acid can reduce bleeding complications during gastric bypass surgery in patients with morbid obesity. This research could lead to safer surgical procedures by better controlling blood loss during and after operation.
Both trials represent important efforts to address specific challenges faced by patients undergoing metabolic surgery, with the goal of improving both the immediate surgical experience and overall patient outcomes. These studies are expected to provide valuable insights that may influence future surgical practices and patient care protocols in weight-loss surgery.
