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NCT05481970Completed

Opioid Free Anesthesia in Obese Patients.

Opioid Free Anesthesia for Upper Limb Surgery in Obese Patients.

Source: ClinicalTrials.gov · Last updated 20 Feb 2024

Brief summary (registry, in English)

Using opioids in the clinical practice of anesthesia was astonishing. They are good analgesics and used widely to modulate perioperative pain, but analgesia with these drugs can be associated with many side effects that may lead to prolongation of hospital stay and recovery period like respiratory depression, delirium, impaired gastrointestinal function, urine retention, post-operative nausea and vomiting (PONV), and addiction. The most significant opioid side effect is respiratory depression. This is especially important in patients suffering from obesity. Obese patients already have a restrictive lung disease leading to decrease in functional residual capacity and total lung compliance. Anesthetics and analgesics specially opioids make these respiratory problems become worse with increasing the incidence of hypoxia. These side effects can be avoided by using opioid free anesthesia (OFA) techniques. Opioid free anesthesia recently become more applicable and popular in different centers, it provides pain control with marked reduction in opioid consumption. However, researches and studies still unable to explore definite explanations or techniques regarding it. The base of OFA is that not only one drug can replace opioids. It is a multimodal anesthesia. Multiple drugs are used to achieve it. They are hypnotics,N-methyl-D-aspartate (NMDA) antagonists (ketamine, magnesium sulfate), sodium channel blockers (local anesthetics), anti-inflammatory drugs (NSAID, dexamethasone), and alpha-2 agonists (dexmedetomidine, clonidine). Regional anesthesia and nerve blocks also have a role. In this study, using OFA the investigators are hoping to achieve a good quality of care to obese patients helping in fast track surgery with less complications and so shorter period of hospital stay

Status (registry)
Completed
Study type
Interventional
Enrollment
76 (actual)
First submitted
20 Jul 2022
Start date
1 Sept 2022
Primary completion date
14 Aug 2023
Lead sponsor
Fayoum University Hospital
Diseases
Obesity
NCT number
NCT05481970

What you commit to

  • Study type: Interventional
  • Participants enrolled: 76
  • From 1 Sept 2022 to the primary completion date, 14 Aug 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known allergy to the drugs will be used in the study.
  • Hepatic, Renal and cardiac diseases in advanced stages.
  • History of epilepsy or seizures.
  • Patients with cerebrovascular disease.

Other

  • Pregnancy and lactation.
  • Addiction or recent use of opioids'
  • Patients will not be able deal with visual analog score(VAS).

Who the study is looking for

  • American Society of Anesthesiologist (ASA) physical status Ⅱ , Ⅲ.
  • body mass index (BMI) ≥30 kg/m2.
  • Have upper limb surgeries (orthopedics, plastic,…) under general anesthesia.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fayoum University
Coordinator of this site? Confirm its status
Al FayyumEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.