opoid free anesthesia
OtherMaintenance Dexmedetomidine 0.2-0.5 µg/kg/h + Lidocaine 1.5 mg/kg/h + Magnesium 10 mg/kg/h; Sevoflurane as required; Atracurium 0.1 mg/kg IV PRN
Other names: Lidocaine, Dexmedetomidine, Magnesium
NCT Number: NCT07306910
1. To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative 2. To quantify opioid consumption reduction achievable through OS strategies 3. To assess the impact of OS on hemodynamic parameters during critical surgical phases 4. To compare recovery metrics (PONV, bowel function, ambulation) 5. To evaluate the safety profile of OS anesthesia
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
The ongoing opioid crisis represents a significant public health challenge, with surgical prescriptions being a major contributor to chronic opioid use and misuse. Recent epidemiological data indicate that 4-6% of opioid- naïve patients develop persistent opioid use postoperatively, with laparoscopic cholecystectomy patients being particularly vulnerable due to moderate postoperative pain . Despite being a minimally invasive procedure, laparoscopic cholecystectomy consistently ranks among the most common general surgical procedures worldwide, with over 1 million performed annually in the United States alone. This frequency amplifies the population-level impact of postoperative prescribing patterns . Previous studies have demonstrated the efficacy of individual components-dexmedetomidine for hemodynamic stabilization, lidocaine infusions for visceral analgesia, and regional techniques like erector spinae plane (ESP) blocks-but their synergistic effects remain underexplored . A recent scoping review highlighted that while opioid-sparing (OS) effects are frequently reported, evidence for clinically meaningful outcomes (e.g., reduced ventilation time, accelerated functional recovery) remains limited . The pathophysiology of post-cholecystectomy pain involves both somatic (abdominal wall) and visceral (diaphragmatic irritation, biliary spasm) components, necessitating a multimodal approach. Opioids inadequately address inflammatory mediators while introducing risks of respiratory depression, postoperative nausea and vomiting (PONV), ileus, and hemodynamic instability. Emerging evidence suggests that α-2 agonists (e.g., dexmedetomidine) and NMDA ant
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Maintenance Dexmedetomidine 0.2-0.5 µg/kg/h + Lidocaine 1.5 mg/kg/h + Magnesium 10 mg/kg/h; Sevoflurane as required; Atracurium 0.1 mg/kg IV PRN
Other names: Lidocaine, Dexmedetomidine, Magnesium
Time frame: 48 hours post operative
Pain intensity at rest will be measured using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Time frame: 48 hours post operative
Cumulative opioid consumption will be measured in morphine milligram equivalents (MME) administered to each patient.
Time frame: 24 hours post operative
Time to extubating; time to Aldrete ≥9
Time frame: 24 hours post operative
time to first demand for rescue analgesia
Time frame: 48 hours post operative
Time in hours from completion of surgery until the patient passes first flatus, representing bowel recovery.
Time frame: 48 hours post operative
Assessment of the patient's ability to ambulate, measured as distance walked in feet or meters within specified postoperative periods.
Contact information is provided by the study sponsor or research team.
Mohamed Bakr Eid, prof
CONTACT
01223213370 ext. +2
Ola Mahmoud Wahba Gnedy, Assistant Prof.
CONTACT
01151121981 ext. +2
Assiut University
Other
Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic Cholecystectomy.
Acronym: OFA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06846333
Geriatric Population, Opioid-free Anesthesia
View Trial DetailsNCT06493396
Dyssomnias, Mental Disorders
View Trial DetailsNCT07310524
Opioid-free Anesthesia
Medan, North Sumatra, Indonesia
View Trial DetailsNCT07307625
General Anesthesia, Laparoscopic Cholecystectomy
Istanbul, Turkey (Türkiye)
View Trial Details