Ongoing Clinical Trials Related to Hypotonia
This article provides information about 2 ongoing clinical trials investigating methods to reverse muscle relaxation during and after surgery. These studies focus on medications that help restore normal muscle function in patients undergoing general anesthesia, with particular attention to elderly patients and the reappearance of muscle weakness.
Clinical trial locations
- Denmark
- Finland
Study on Muscle Relaxation Reappearance in Patients Under General Anesthesia Using Glycopyrronium Bromide and Neostigmine Methylsulfate
This trial, conducted in Finland, examines how muscle relaxation can sometimes return after it has been reversed during surgery. The study focuses on understanding how often this happens when using a medication called Glycostigmin, which contains two active substances: glycopyrronium bromide and neostigmine methylsulfate.
Main focus: The primary goal is to monitor how frequently muscle relaxation reappears after being reversed with neostigmine during general anesthesia. This is important because sometimes muscles may not fully regain their normal function right away, even after the reversal medication is given. The medication is delivered directly into the bloodstream through an intravenous infusion, and patients are observed over a short period to assess its effectiveness in preventing the return of muscle relaxation.
Investigational drug: The study uses neostigmine, a medication that helps restore normal muscle function by increasing the levels of a chemical that stimulates muscle movement. It works by inhibiting an enzyme called acetylcholinesterase, which increases acetylcholine at the points where nerves meet muscles, thereby restoring muscle function.
Who can participate: The study is open to adults between 18 and 65 years old who have a Body Mass Index below 35 and are classified as ASA risk class 1-2, meaning they are in good health or have only mild health conditions. Both men and women can join.
Who cannot participate: People with known allergies to neostigmine or similar medications, those with neuromuscular disorders such as myasthenia gravis, individuals taking medications that might interfere with the study drug, patients with severe kidney or liver disease, pregnant or breastfeeding women, those who participated in another trial within the last 30 days, people with a history of substance abuse, and anyone unable to provide informed consent are excluded from the study.
Study on Reversing Muscle Relaxation in Elderly Patients (75+) Using Sugammadex or Neostigmine/Glycopyrrolate During Laparoscopic Surgery
This trial, taking place in Denmark, compares two different medications used to reverse muscle relaxation in elderly patients undergoing robotic-assisted laparoscopic surgery. The study is designed to determine which medication works faster in helping patients regain normal muscle function after surgery.
Main focus: The study aims to compare the effectiveness of neostigmine combined with glycopyrrolate versus sugammadex in reversing muscle relaxation in elderly patients. Researchers will measure how quickly patients’ muscle function returns to normal by checking their ability to grip objects, lift their head, and follow objects with their eyes. The study is blinded, meaning neither patients nor researchers know which medication each patient receives, ensuring unbiased results.
Investigational drugs: The trial tests two options. Neostigmine is used in combination with glycopyrrolate, where neostigmine increases the levels of acetylcholine to help muscles contract, and glycopyrrolate reduces side effects such as excessive saliva or slow heart rate. The alternative medication is sugammadex, which works differently by directly binding to the muscle relaxant, helping the body remove it more quickly and potentially leading to faster recovery of muscle strength.
Who can participate: Patients must be 75 years old or older, scheduled for robotic-assisted laparoscopic surgery under general anesthesia, and able to provide informed consent after understanding the study. They must have an ASA physical status classification of I to IV, covering a range from healthy to having severe health issues, and must be able to read and understand Danish.
Who cannot participate: Patients who are not undergoing laparoscopic robot-assisted surgery, those younger than 75 years old, and individuals who are part of vulnerable populations requiring special protection or care are excluded from the study.
Summary
These two clinical trials focus on important aspects of muscle relaxation reversal during and after surgery. The Finnish study investigates the reappearance of muscle relaxation after it has been reversed, while the Danish study compares two different medications for reversing muscle relaxation specifically in elderly patients aged 75 and older.
Both trials use neostigmine as one of their investigational drugs, highlighting its established role in reversing muscle relaxation during anesthesia. The Danish study adds another dimension by comparing neostigmine/glycopyrrolate with sugammadex, a newer medication that works through a different mechanism.
Geographically, these trials are concentrated in Nordic countries, with one trial each in Finland and Denmark. The Finnish study targets a broader adult population aged 18 to 65, while the Danish study focuses exclusively on elderly patients, reflecting growing medical attention to age-specific treatment approaches in anesthesia and surgery.
These studies aim to improve patient safety and recovery outcomes by better understanding how to manage muscle relaxation during surgical procedures, ultimately contributing to more effective and safer anesthesia practices.