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Background Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery.
Methods and analysis:
This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 406 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay.
Discussion:
The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.
gastrointestinal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-Based Anaesthesia (OBA) Group | Active Comparator | Patients receive conventional opioid-based general anaesthesia, including sufentanil and remifentanil during surgery and sufentanil-based patient-controlled intravenous analgesia (PCIA) postoperatively. |
|
| Opioid-Free Anaesthesia (OFA) Group | Experimental | Patients receive opioid-free anaesthesia using a standardized multimodal regimen (dexmedetomidine, esmolol, and esketamine) for intraoperative management and esketamine-based PCIA postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Continuous infusion at 0.5-1.0 μg/kg/h during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of POD at discharge or within 7 days after surgery. | The proportion of participants who develop postoperative delirium, assessed either at discharge or within 7 days after surgery. Diagnosis of POD will be based on standardized clinical assessment tools (e.g., Confusion Assessment Method, CAM).Results will be reported as the percentage of participants (%). | Discharge or within 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day All-Cause Mortality | The proportion of participants who die from any cause during the initial hospitalization or within 30 calendar days following the index surgical procedure.The proportion of participants who die from any cause during the initial hospitalization or within 30 calendar days following the index surgical procedure. Results will be reported as the percentage of participants (%). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Haemodynamic Changes | Changes in mean arterial pressure and heart rate recorded during surgery. Results will be reported as the mean change from baseline (mmHg or beats per minute). | Intraoperative (from anesthesia induction to surgical closure) |
| Quality of Recovery-15 (QoR-15) Scores |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongtao Sun, Ph.D. in Anesthesiology | Contact | +86 18660795201 | ytsun@sdfmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital | Jinan | Shandong | 250014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40721742 | Derived | Du Y, Liu M, Yang X, Wu J, Gao X, Liu Q, Chen L, Sun X, Zhang M, Sun Y. Effect of opioid-free anaesthesia on postoperative delirium in elderly patients undergoing gastrointestinal surgery: study protocol for a single-centre, prospective, randomized controlled trial. BMC Geriatr. 2025 Jul 28;25(1):554. doi: 10.1186/s12877-025-06145-8. |
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| Esketamine | Drug | Induction dose 0.3-0.5 mg/kg; maintenance 0.2-0.5 mg/kg/h; 0.02 mg/kg at closure; PCIA: 1.5 mg/kg in 100 mL saline |
|
| Esmolol | Drug | Maintenance 20-100 μg/kg/min during surgery |
|
| Sufentanil | Drug | 0.3-0.5 μg/kg induction; 0.15 μg/kg at closure; 2 μg/kg in 100 mL for PCIA |
|
| Remifentanil | Drug | 0.2-1.0 μg/kg/min maintenance |
|
| Up to 30 days after surgery |
QoR-15 scores assessed at 24 hours, 48 hours, and 72 hours after surgery. Results will be reported as the total score on the QoR-15 scale (range 0-150). |
| 24, 48, and 72 hours after surgery |
| Postoperative Complications | Incidence of complications during postoperative hospitalization, including lung infection, urinary tract infection, cardiovascular and cerebrovascular accidents, abnormal liver function, postoperative bleeding, incision infection, deep venous thrombosis of the lower extremities, electrolyte imbalance, and hypoalbuminemia. Results will be reported as the percentage of participants (%). | From day of surgery through hospital discharge, up to 30 days |
| Pain Numerical Rating Scale (NRS) Score at 72 Hours | Pain intensity assessed using the NRS scale (0-10) at 72 hours after surgery. Results will be reported as the mean NRS score. | 72 hours after surgery |
| Incidence of Nausea and Vomiting at 72 Hours | The proportion of participants experiencing nausea and/or vomiting at 72 hours after surgery. Results will be reported as the percentage of participants (%). | 72 hours after surgery |
| Morphine Milligram Equivalent (MME) Consumption for Analgesics at 72 Hours | Total opioid consumption converted to morphine milligram equivalents (MME) at 72 hours after surgery. Results will be reported as total MME (mg). | 72 hours after surgery |
| Duration of Anaesthesia | Time from induction of anaesthesia to discontinuation of anaesthetic agents. Results will be reported in minutes. | From administration of anaesthetic agents to discontinuation of anaesthetic agents， up to 2 hours |
| Duration of Surgery | Time from skin incision to the last suture. Results will be reported in minutes. | From skin incision to completion of wound closure, up to 2 hours |
| Length of Stay in the Post-Anesthesia Care Unit (PACU) | Time from arrival in the PACU to discharge from the PACU. Results will be reported in minutes. | From PACU admission to PACU discharge, measured in minutes, up to 60 minutes |
| Length of Hospital Stay | Total number of days from surgery to hospital discharge. Results will be reported in days. | From day of surgery to hospital discharge, up to 30 days |
| Long-Term Cognitive Function at 6 Months | Cognitive function assessed at 6 months after surgery using standardized cognitive testing methods. Results will be reported as cognitive assessment scores. | 6 months after surgery |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| C000629870 | Esketamine |
| C036604 | esmolol |
| D017409 | Sufentanil |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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