Gastric Cancer, Thoracic Epidural Analgesia
Conditions
Brief summary
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.
Detailed description
See Brief Summary and study protocol sections for complete description.
Interventions
PROCEDURENeuromuscular blocker usage
The patients were followed up, the total amount of muscle relaxant used was determined, intraoperative effects and postoperative analgesic usage
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Because of the nature of thoracic epidural catheterization, participants and intraoperative anesthesia providers could not be blinded to group allocation. However, postoperative outcome assessors were blinded.
Intervention model description
Randomized prospective, controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of recovery from TOF 25% to TOF 90% (DUR25-90) | During surgery, from administration of the initial intubating dose of rocuronium until recovery to train-of-four ratio 90% (up to 6 hours) | Time interval between spontaneous recovery to TOF 25% and recovery to TOF 90% following the initial intubating dose of rocuronium, assessed using quantitative train-of-four (TOF) monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Supplemental NMBA requirement | During surgery (up to 6 hours) | Number of patients requiring additional rocuronium doses |
| Total intravenous fentanyl consumption | During surgery, from anesthesia induction until skin closure (up to 6 hours) | Total intraoperative fentanyl dose (µg), including induction and supplemental boluses |
| Postoperative pain score assessed by Visual Analog Scale (VAS) | At PACU admission and 30 minutes after PACU admission | Visual Analog Scale (VAS) pain score ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain, assessed at PACU admission and 20 minutes after PACU admission. |
| Intraoperative hypotension | Time Frame: During surgery (up to 6 hours) | Incidence of MAP decrease \>20% from baseline or SBP \<90 mmHg |
| Postoperative nausea and vomiting | During PACU stay (up to 2 hours after surgery) | Incidence of PONV |
| Residual neuromuscular blockade assessed by train-of-four ratio | Within 15 minutes of PACU admission | Incidence of residual neuromuscular blockade defined as train-of-four (TOF) ratio \<0.7 measured quantitatively at PACU admission. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSchool of Medicine Department of Anesthesiology and Reanimation
Yuzuncu Yil University
Outcome results
None listed