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Evaluation of the efficacy and safety of epidural hydromorphone for analgesia in radical esophagectomy

The Efficacy and Safety of an Opioid-Sparing Strategy Based on Epidural Hydromorphone for Analgesia in Radical Esophagectomy: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128614
Enrollment
Unknown
Registered
2026-07-23
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer death worldwide. Esophageal cancer is characterized by insidious onset, rapid progression, and poor prognosis, with a marked disparity in outcomes between early and late detection. The 5-year survival rate for patients with early-stage disease can reach 90%, whereas for those with advanced-stage disease, it is

Interventions

Intervention Group (Group H):Dexmedetomidine at a dose of 0.6 µ g/kg was administered intravenously within 15 to 20 minutes. Twenty minutes before induction, hydromorphinone at a dose of 0.6mg was slo
Control Group (Group S):Dexmedetomidine at a dose of 0.6 µ g/kg was administered intravenously within 15 to 20 minutes. Twenty minutes before induction, 10ml of normal saline was slowly injected throu

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 - 80 years old; 2. ASA classification: I - III grade; 3. The planned elective minimally invasive McKeown esophageal cancer radical surgery (combined thoracoscopic and laparoscopic approach) involves three-field or two-field lymph node dissection, gastric tube reconstruction, and cervical anastomosis. The surgery is divided into three stages: The first stage (thoracic stage): Thoracoscopic esophageal dissection, mediastinal lymph node dissection (including subcarinal, left and right recurrent laryngeal nerve chains, etc.); the second stage (abdominal stage): Laparoscopic gastric dissection, abdominal lymph node dissection and tube-shaped stomach construction; the third stage (cervical stage): Cervical small incision esophagogastric cervical anastomosis; 4. Voluntary participation and signing of a written informed consent form;

Exclusion criteria

Exclusion criteria: 1. Contraindications for epidural puncture (coagulation dysfunction, infection at the puncture site, severe spinal deformity, etc.); 2. Known to be allergic to the research drugs (hydromorphinone, sufentanil, ropivacaine); 3. Long-term use of opioid drugs before the operation (more than 3 months) or suffering from chronic pain syndrome; 4. Severe liver and kidney dysfunction (Child-Pugh grade C or eGFR 180 mmHg), severe arrhythmia, symptomatic heart failure (NYHA grade III-IV), or severe bradycardia (HR<50 beats per minute); 6. Previous history of ipsilateral chest surgery; 7. Communication barriers, cognitive dysfunction, or inability to cooperate with epidural operations or pain assessment; 8. Pregnant or lactating women;

Design outcomes

Primary

MeasureTime frame
Pain intensity within 72 hours postoperatively (area under the curve [AUC] of the visual analog scale [VAS] at rest;Analgesia-related indicators;

Secondary

MeasureTime frame
Intraoperative stress response level;Pain intensity within 72 hours postoperatively (area under the curve of coughing VAS);Postoperative clinical outcomes;Intraoperative hemodynamic stability;Incidence and severity of postoperative delirium;Perioperative cumulative opioid consumption (in morphine milligram equivalents);Incidence of adverse reactions;Incidence and severity of chronic postoperative pain;Incidence of serious adverse events;Rehabilitation process;Quality of recovery;

Countries

China

Contacts

Public ContactZhu Yejing

Zhejiang Cancer Hospital

zhuyejing1983@126.com+86 571 88122106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026