Clinical trial · Interventional
General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia
The Effect of General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia on Neuromuscular Block
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled trial investigated whether adding thoracic epidural analgesia to general anesthesia affects intraoperative neuromuscular blockade and opioid requirements in patients undergoing gastric cancer surgery. Sixty ASA I-II patients aged 18-65 years were randomized to receive either general anesthesia alone (GA, n=30) or general anesthesia with thoracic epidural analgesia (GAE, n=30). Neuromuscular blockade was induced with rocuronium and monitored quantitatively using train-of-four (TOF) stimulation. The primary outcome was the time from TOF 25% to TOF 90% recovery (DUR25-90). Secondary outcomes included supplemental neuromuscular blocker requirements, intravenous opioid consumption, postoperative pain scores, and adverse events. The study was completed in January 2024.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Thoracic Epidural Analgesia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neuromuscular blocker usage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Group general anesthesia (GA)
- description
- Anesthesia induction was applied to all patients with 1mg/kg lidocaine, 1μcg/kg fentanyl, 2mg/kg propofol, 0.6mg/kg rocuronium. When the TOF value was 0, the patients were intubated with an endotracheal tube. In the maintenance, desflurane at 8% concentration was used in a mixture of 50% O2 + 50% air. The time to reach 25% of the TOF value was noted in both groups. 0.1mg/kg rocuronium will be added to patients who reach 0.25.It was planned to administer 0.05mg/kg morphine 30 minutes before the end of the operation to the GA group.
- interventionNames
- Procedure: Neuromuscular blocker usage
- type
- EXPERIMENTAL
- label
- Group General anesthesia and Thoracal epidural (GAE)
- description
- Electrodes were placed for TOF monitoring after thoracic epidural catheterization in the GAE group. Anesthesia induction was applied to all patients with 1mg/kg lidocaine, 1μcg/kg fentanyl, 2mg/kg propofol, 0.6mg/kg rocuronium. When the TOF value was 0, the patients were intubated with an endotracheal tube. In the maintenance, desflurane at 8% concentration was used in a mixture of 50% O2 + 50% air. The time to reach 25% of the TOF value was noted in both groups. 0.1mg/kg rocuronium will be added to patients who reach 0.25.The number of additional muscle relaxant requirements made will be recorded. In the GAE group, 5 ml of epidural medication will be given per hour. When the TOF value reached 70%, inhaler anesthetics were discontinued and the patients with a TOF value of 90% were extubated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria Age 18-65 years ASA physical status I-II Scheduled for elective open gastric cancer surgery Exclusion Criteria Severe cardiac, pulmonary, hepatic, or renal disease Coagulopathy or bleeding diathesis Local infection at epidural insertion site Allergy to study medications Electrolyte or acid-base disturbances Chronic use of anticonvulsants, antiarrhythmics, or cholinesterase inhibitors Pregnancy Refusal to participate Contraindications to thoracic epidural analgesia
References
Publications (0)
Data not yet available