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Study on the Effects of Opioid-Free Anesthesia with Ketamine Hydrochloride on Oxygen Levels in Patients Undergoing Bariatric Surgery

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 patients undergoing bariatric surgery, which is a type of surgery aimed at helping with weight loss. The study is investigating the use of a treatment called Opioid-Free Anesthesia during the surgery. This type of anesthesia does not use opioids, which are commonly used pain-relieving drugs. Instead, the study will use a medication called Ketamine Hydrochloride, known by the product name KETOLAR 50 mg/ml solution for injection. Ketamine Hydrochloride is administered through an injection into a vein, a method known as intravenous administration.

The purpose of the study is to evaluate how Opioid-Free Anesthesia affects the oxygen levels in the blood during the first six hours after surgery, compared to conventional anesthesia that includes opioids. This is measured by looking at the Arterial Oxygen Pressure/Inspired Fraction of Oxygen (PaO2/FiO2) ratio, which is a way to assess how well the lungs are working to get oxygen into the blood.

Participants in the study will receive either the Opioid-Free Anesthesia with Ketamine Hydrochloride or a conventional anesthesia. The study will monitor the patients' oxygen levels and other health indicators during and after the surgery to gather data on the effectiveness and safety of the Opioid-Free Anesthesia approach. The trial aims to provide insights that could improve anesthesia practices for patients undergoing bariatric surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is determined based on age (18 or over) and the need for laparoscopic vertical gastrectomy for bariatric surgery.

    Informed consent is required to participate in the study.

  2. Step 2

    Pre-surgery preparation

    Preparation for surgery involves standard pre-operative procedures.

    No specific medications are administered at this stage related to the study.

  3. Step 3

    Surgery and anesthesia

    During surgery, Opioid-Free Anesthesia is administered to evaluate its effect on oxygenation.

    The anesthesia includes the use of ketamine hydrochloride, administered intravenously as KETOLAR 50 mg/ml solution for injection.

  4. Step 4

    Postoperative monitoring

    The primary focus is on monitoring the Arterial Oxygen Pressure/Inspired Fraction of Oxygen (PaO2/FiO2) ratio during the first 6 hours after surgery.

    This monitoring helps assess the effectiveness of the Opioid-Free Anesthesia compared to conventional methods.

  5. Step 5

    Follow-up

    Regular follow-up appointments are scheduled to monitor recovery and gather data for the study.

    The study is estimated to conclude by July 1, 2025.

Who can join the trial?

3 criteria

  • Patients must be **18 years old or older**.
  • Patients must be scheduled for a **laparoscopic vertical gastrectomy**, which is a type of surgery for weight loss.
  • Patients must **agree to participate** by giving their informed consent, which means they understand the study and agree to take part.

Who cannot join the trial?

1 criterion

  • Patients who have had bariatric surgery cannot participate. Bariatric surgery is a type of surgery that helps with weight loss by making changes to the digestive system.
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Investigated drugs

  • Opioid-Free Anesthesia

    is a type of anesthesia used during surgery that does not include opioids, which are commonly used pain-relieving medications. This approach aims to manage pain and maintain stable vital signs without the use of opioids, potentially reducing side effects associated with opioid use, such as respiratory depression and addiction. In this trial, the focus is on how this type of anesthesia affects oxygen levels in the blood during and after bariatric surgery.

  • Conventional Anesthesia

    typically includes the use of opioids to manage pain and maintain patient comfort during surgery. Opioids are effective in controlling pain but can have side effects like nausea, constipation, and respiratory issues. This trial compares conventional anesthesia with opioid-free anesthesia to see which method better maintains oxygen levels in the blood during and after bariatric surgery.

What is already known about the treatment

Opioid-Free Anesthesia – This approach is administered intravenously and is used during surgical procedures, such as bariatric surgery, to manage pain without the use of opioids. It is currently being studied in clinical trials to assess its effectiveness and safety compared to traditional opioid-based anesthesia. The main therapeutic indication is to provide pain relief and improve oxygenation during and after surgery. The mechanism of action involves using alternative medications that target different pain pathways, reducing the need for opioids. It falls under the pharmacological classification of anesthetics and analgesics.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. The progression of obesity can lead to increased risk of various health issues, including heart disease, diabetes, and joint problems. It often results from a combination of genetic, behavioral, and environmental factors. Over time, obesity can lead to complications such as metabolic syndrome and increased strain on the body's organs. Managing obesity involves lifestyle changes, and in some cases, medical or surgical interventions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519722-20-00Estimated enrolment72 patientsSponsorFundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

sourced from the EU Clinical Trials Register and site verification

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