Opioid-free Anesthesia and Postoperative Delirium
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorQianfoshan Hospital
About this trial
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. This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 654 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. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who plan to undergo elective gastrointestinal surgery under general anaesthesia
Age ≥65 years
American Society of Anaesthesiologists (ASA) grade I-III
Body mass index (BMI) of 18.0-30.0 kg/m²
Disqualifiers
Patients undergoing emergency surgery
Patients with language disorders or severe hearing or vision impairment that prevent communication
Patients with a history of neurological and psychiatric disorders, including Alzheimer's disease (AD), other types of dementia, stroke, and psychosis
Patients with long-term use of psychotropic medications (such as clozapine, risperidone, olanzapine, haloperidol, and chlorpromazine)
Trial design
Design model
Parallel
Treatments tested in this trial
OFA group
DrugIn the OFA group, anaesthesia will be induced with 1.5-2.5 mg/kg propofol, 0.3-0.5 mg/kg esketamine, and 0.6-1.0 mg/kg rocuronium. Endotracheal intubation or laryngeal mask placement will be performed when the BIS value is observed at 40-60. Intraoperative continuous intravenous infusion of 2-6 mg/kg/h propofol, 0.5-1.0 μg/kg/h dexmedetomidine, 0.2-0.5 mg/kg/h esketamine, 5-6 μg/kg/min rocuronium bromide, 20-100 μg/kg/min esmolol, and inhaled 1% sevoflurane will be utilized to maintain anaesthesia. At the end of the procedure (after the last suture), all maintenance drugs will be discontinued. Afterwards, 8 mg of ondansetron and 0.2 mg/kg esketamine-assisted sufentanil will be intravenously administered. Postoperative analgesia will be performed by using an intravenous patient-controlled analgesia pump consisting of 1.5 mg/kg esketamine and 16 mg of ondansetron. The volume will be adjusted to 100 mL in 0.9% normal saline; moreover, the continuous infusion rate will be set at 2 mL/h, an
OBA group
DrugIn the OBA group, anaesthesia will be induced with 1.5-2.5 mg/kg propofol, 0.6-1.0 mg/kg rocuronium, and 0.3-0.5 μg/kg sufentanil. Endotracheal intubation or laryngeal mask airway insertion will be performed when the BIS value decreases to 40-60. During surgery, 2-6 mg/kg/h propofol, 0.2-1.0 μg/kg/min remifentanil, and 5-6 μg/kg/min rocuronium will be continuously pumped to maintain anaesthesia. Both groups will receive inhalation of 1% sevoflurane during anaesthesia maintenance. At the end of the procedure (after the last suture), all maintenance drugs will be discontinued. Afterwards, 8 mg of ondansetron and 0.15 μg/kg sufentanil will be intravenously injected. Postoperative analgesia will be performed by using an intravenous patient-controlled analgesia pump; the formulation will involve 2 μg/kg sufentanil and 16 mg of ondansetron, which will be diluted to 100 mL with 0.9% normal saline. Moreover, the background infusion rate will be set at 2 mL/h, and the lockout interval will be 1
Treatment groups
174 Participants
are divided into 2 treatment groupsGroup A: Opioid-free anaesthesia groupActive comparator 1 intervention
Group B: opioid-based anaesthesia groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of postoperative delirium (POD) within 7 days after surgery or at discharge
Time frame
7 days after surgery or at dischargeSecondary outcomes
1
All-cause mortality within 30 days after surgery
Time frame
30 days after surgery2
Serum tumour necrosis factor-α (TNF-α, pg/mL) concentration
Blood samples are collected at 5 predefined perioperative time points: 10 minutes after anaesthesia induction (baseline), 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, 24 hours post-surgery, and 48 hours post-surgery. Serum TNF-α concentration is measured in duplicate by enzyme-linked immunosorbent assay (ELISA). Each time point yields a separate value; these values are not aggregated into a single composite measure. All five time-specific values will be analysed separately using repeated measures models to compare changes over time between the two treatment groups.
Time frame
10 minutes after anaesthesia induction; 10 minutes and 1 hour after pneumoperitoneum; and 24 hours and 48 hours after surgery3
Serum cortisol concentration (nmol/L)
Time frame
10 minutes after anaesthesia induction; 10 minutes and 1 hour after pneumoperitoneum; and 24 hours and 48 hours after surgery4
Quality of Recovery-15 (QoR-15) score
The QoR-15 is a 15-item patient-reported questionnaire that measures quality of recovery after surgery and anesthesia. Each item is scored from 0 (none of the time) to 10 (all of the time). Total scores range from 0 (worst possible recovery) to 150 (best possible recovery). Higher scores indicate a better outcome.
Time frame
24 hours, 48 hours, and 72 hours after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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