NCT05481970

Opioid Free Anesthesia in Obese Patients.

Completed NA Last updated 20 February 2024

What this trial tests

NA trial testing dexmedetomidine,ketamine,lidocaine,propofol in Opioid Free Anesthesia in 76 participants. Completed in 5 November 2023.

Timeline

1 September 2022

Primary endpoint
14 August 2023

5 November 2023

Quick facts

Lead sponsor	Fayoum University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	76
Start date	1 September 2022
Primary completion	14 August 2023
Estimated completion	5 November 2023
Sites	1 location across Egypt

Drugs / interventions tested

• dexmedetomidine,ketamine,lidocaine,propofol — full drug profile →
• fentanyl,propofol

Conditions studied

• Opioid Free Anesthesia — all drugs for Opioid Free Anesthesia →

Sponsor

Fayoum University Hospital

Who can join

Adults 18 to 60, any sex, with Opioid Free Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Opioid-Free Anesthesia for Upper Limb Surgery in Obese Patients as a Day Case Surgery: A Prospective Observational Study.
   Ahmed Abdelghaffar R, Ahmed Hamed M, Magdy Basiony M, Fouad Algyar M, et al · · 2024 · cited 1× · PMID 40078645 · DOI 10.5812/aapm-150997