Dexmedetomidine-Esketamine Combination on Depression and Anxiety After Laparoscopic Ureteral Reconstruction
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
Anxiety and depressive symptoms are prevalent in patients undergoing surgical repair for ureteral stricture, driven by chronic pain, renal function concerns, and surgical uncertainty. Dexmedetomidine has anxiolytic and antidepressant effects but may increase bradycardia and hypotension; esketamine provides rapid antidepressant efficacy but may cause psychiatric side effects. Preliminary studies showed that combined use of low-dose dexmedetomidine and esketamine reduced the prevalence of postoperative depressive symptoms without increasing adverse events. This study is designed to test the hypothesis that perioperative use of low-dose dexmedetomidine-esketamine combination may relieve postoperative depressive symptoms and anxiety in patients undergoing laparoscopic ureteral reconstruction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years;
Diagnosed with ureteral stricture and scheduled for elective laparoscopic ureteral reconstruction under general anesthesia;
Requiring patient-controlled intravenous analgesia after surgery.
Disqualifiers
Preoperative inability to communicate due to coma, delirium, severe dementia, or language barrier;
History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
Presence of preexisting left ventricular ejection fraction (LVEF) < 30%, sick sinus syndrome, severe sinus bradycardia (heart rate < 50 beats/min), or atrioventricular block above grade II without pacemaker implanted;
Uncontrolled hyperthyroidism or history of pheochromocytoma;
Trial design
Design model
Parallel
Treatments tested in this trial
Combined dexmedetomidine-esketamine administration
DrugDuring anesthesia, a loading dose (0.8 ml/kg/h) of dexmedetomidine-esketamine (DEX-ESK) combination (DEX 1 ug/ml; ESK 0.5 mg/ml) will be infused after anesthesia induction for 30 min (DEX 0.4 ug/kg; ESK 0.2 mg/kg), followed by a continuous infusion at 0.1 ml/kg/h (DEX 0.1 ug/kg/h; ESK 0.05 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.25 mg/ml), and sufentanil (1.0 ug/ml), programmed to deliver 2-ml boluses (DEX 3.0 ug, ESK 0.5 mg, and sufentanil 2.0 ug) with an 8-minute lockout interval and a 1-ml/h (DEX 1.5 ug/h, ESK 0.25 mg/h, and sufentanil 1.0 ug/h) background infusion, and used for up to 48 hours.
Placebo administration
DrugDuring anesthesia, a loading dose (0.8 ml/kg/h) of normal saline will be infused after anesthesia induction for 30 min, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1.0 ug/ml), programmed to deliver 2-ml boluses (sufentanil 2.0 ug) with an 8-minute lockout interval and a 1-ml/h (sufentanil 1.0 ug/h) background infusion, and used for up to 48 hours.
Treatment groups
658 Participants
are divided into 2 treatment groupsGroup A: Combined dexmedetomidine-esketamine groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of depressive symptoms on postoperative day 7
Depressive symptoms will be screened using the Patient Health Questionnaire-9 (PHQ-9; total scores range from 0 to 27, with higher scores indicating more severe symptoms). A PHQ-9 score ≥5 is defined as presence of depressive symptoms.
Time frame
On postoperative day 7.Secondary outcomes
1
Incidence of moderate-to-severe catheter-related bladder discomfort (CRBD) within 24 hours after surgery
CRBD is defined as a strong desire to urinate or discomfort in the pubic region that occurs after awakening from anesthesia. The occurrence of CRBD will be assessed at 10 minutes, 30 minutes, 60 minutes, 2 hours, and 6 hours after surgery, and twice daily during the first postoperative day (8:00-10:00 am, or 6:00-8:00 pm). The severity of CRBD is divided into four levels: 1- None, even when asked, no discomfort is reported; 2- Mild, only report discomfort during questioning; 3-Moderate, reported discomfort without inquiry, but without behavioral reactions; 4-Severe, with the patient actively reporting discomfort and behavioral reactions (observable behavioral reactions include limb movement, strong vocal reactions, or attempts to remove the catheter).
Time frame
Up to 24 hours after surgery.2
Prevalence of anxiety symptoms on postoperative day 7
Anxiety symptoms will be screened using the Generalized Anxiety Disorder-7 (GAD-7; total scores range from 0 to 21, with higher scores indicating more severe anxiety). A GAD-7 score ≥5 is defined as presence of anxiety symptoms.
Time frame
On postoperative day 7.3
Prevalence of depressive symptoms 30 days after surgery
Depressive symptoms will be screened using the Patient Health Questionnaire-9 (PHQ-9; total scores range from 0 to 27, with higher scores indicating more severe symptoms). A PHQ-9 score ≥5 is defined as presence of depressive symptoms.
Time frame
At 30 days postoperatively.Other outcomes
1
Area under curve (AUC) of pain intensity within 48 hours after surgery
Pain intensity will be assessed at 10 minutes, 30 minutes, 60 minutes, 2 hours, and 6 hours after surgery, and twice daily during the first postoperative day (8:00-10:00 am, or 6:00-8:00 pm) using an 11-point Numeric Rating Scale (0 = no pain, 10 = the worst pain). The AUC of pain intensity is calculated by summing the trapezoidal areas under the pain intensity data points between each pair of consecutive observations within 48 hours after surgery.
Time frame
Within 48 hours after surgery.2
Percentage using rescue analgesics within 48 hours after surgery
The percentage of patients requiring rescue analgesics within 48 hours after surgery.
Time frame
Within 48 hours after surgery.3
Subjective sleep quality on the night of surgery and the first postoperative night
Subjective sleep quality during the previous night will be assessed the next morning (between 8:00 and 10:00 am) using an 11-point Numeric Rating Scale (0 = the best sleep, 10 = the worst sleep).
Time frame
From the night of surgery until the first night after surgery.4
Length of hospital stay after surgery
Length of hospital stay after surgery.
Time frame
Up to 30 days after surgery.Sponsors and contacts
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Source ClinicalTrials.gov
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