Not recruiting

Study on Morphine, Lidocaine, and Naloxone for Patients with Obesity and Sleep Apnea

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how the body processes and responds to morphine hydrochloride, a medication commonly used for pain relief, in individuals who are healthy as well as those with obesity and obstructive sleep apnea. The study aims to gather important information about the safety and effectiveness of morphine, especially for patients undergoing surgery who have these conditions. By doing so, the study hopes to improve pain management strategies, ensuring effective pain relief with minimal side effects.

Participants in the study will receive morphine, and researchers will observe how it is absorbed and how it affects the body. The study will also involve 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. The study will take place over a short period, with participants receiving these medications through injections.

The goal is to develop a more personalized approach to treating pain, particularly for those with obesity and sleep apnea, by understanding how these conditions affect the way morphine works in the body. This research could lead to better pain management practices for surgical patients, especially those undergoing weight-loss surgery. The study is expected to provide valuable insights that could benefit future patients by tailoring pain relief methods to individual needs.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring the presence of obesity and obstructive sleep apnea.
Step 2
Baseline measurements
Baseline measurements are taken to establish a starting point for the study. This may involve various tests to assess current health status.
Step 3
Medication administration
Participants receive morphine hydrochloride through IV injection or IV infusion. The dosage and frequency are determined by the study protocol and are administered under medical supervision.
Additional medications such as naloxone hydrochloride and lidocaine hydrochloride may be used as needed, following the same administration routes.
Step 4
Monitoring and testing
Participants are closely monitored for any side effects or reactions to the medication. Regular tests are conducted to measure the concentration of morphine in the blood and assess its effects.
Quantitative sensory testing is performed to evaluate the response to different stimuli, such as heat, cold, and pressure.
Step 5
Follow-up assessments
Follow-up assessments are scheduled to track progress and gather data on the effectiveness and safety of the treatment. These assessments help in understanding the impact of obesity and sleep apnea on morphine pharmacology.
Step 6
Study completion
Upon completion of the study, participants undergo a final evaluation to summarize the findings and ensure their well-being. The study aims to conclude by January 31, 2025.

Who can join the trial?

5 criteria

You must have obesity.
You must have obstructive sleep apnoea, a condition where breathing stops and starts during sleep.
You must be an adult, as the study includes people aged 18 and older.
Both men and women can participate.
You should not belong to a vulnerable population, meaning you should be able to give informed consent and participate without additional risks.

Who cannot join the trial?

4 criteria

Patients who are not suffering from obesity or obstructive sleep apnea cannot participate.
Patients who are not undergoing bariatric surgery cannot participate. Bariatric surgery is a type of surgery to help with weight loss.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may be at a higher risk of harm or exploitation.

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Investigated drugs

Morphine is a medication used to relieve severe pain. It works by changing the way the brain and nervous system respond to pain. In this clinical trial, researchers are studying how morphine behaves in the body and how it affects people, especially those who are obese or have obstructive sleep apnea. The goal is to understand how to use morphine safely and effectively for pain relief during and after surgery, with a focus on minimizing side effects. This study aims to help doctors provide better, personalized pain management for patients undergoing surgery.

What is already known about the treatment

Morphine – Morphine is typically administered through injection or orally in the form of tablets or liquid. It is a well-established medication in the medical field, widely documented in medical literature for its use in pain management. The main therapeutic indications for morphine include the relief of acute and chronic pain, particularly in surgical settings. At the molecular level, morphine works by binding to opioid receptors in the brain, which helps to block the sensation of pain. It is classified pharmacologically as an opioid analgesic. This trial aims to explore its safety and effectiveness in patients with obesity and obstructive sleep apnea, especially during and after surgery, to ensure effective pain relief with minimal side effects.

Investigated diseases

Obesity
Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this excess energy is stored as fat, resulting in increased body weight. Obesity can progress gradually, often starting with slight weight gain that becomes more significant over the years. It is associated with various metabolic changes, including increased fat cell size and number. As obesity progresses, it can lead to complications affecting multiple body systems.
Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA) is a sleep disorder characterized by repeated episodes of partial or complete blockage of the upper airway during sleep. This obstruction leads to reduced or completely stopped airflow, causing breathing pauses. These episodes can result in fragmented sleep and reduced oxygen levels in the blood. OSA often begins with mild symptoms, such as snoring, and can progress to more severe forms with frequent apneas. The condition can lead to daytime sleepiness and fatigue due to disrupted sleep patterns. Over time, OSA can contribute to cardiovascular and metabolic issues.