Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
See Brief Summary and study protocol sections for complete description.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group general anesthesia (GA) | Sham Comparator | 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. |
|
| Group General anesthesia and Thoracal epidural (GAE) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular blocker usage | Procedure | The patients were followed up, the total amount of muscle relaxant used was determined, intraoperative effects and postoperative analgesic usage |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of recovery from TOF 25% to TOF 90% (DUR25-90) | 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. | During surgery, from administration of the initial intubating dose of rocuronium until recovery to train-of-four ratio 90% (up to 6 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Supplemental NMBA requirement | Number of patients requiring additional rocuronium doses | During surgery (up to 6 hours) |
| Total intravenous fentanyl consumption | Total intraoperative fentanyl dose (µg), including induction and supplemental boluses |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| School of Medicine Department of Anesthesiology and Reanimation | Yuzuncu Yil University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arzu Esen Tekeli | Van | Turkey | 65100 | Turkey (Türkiye) |
Personal data of participating patients will not be shared in any way.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Randomized prospective, controlled study
Not provided
Not provided
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.
|
| During surgery, from anesthesia induction until skin closure (up to 6 hours) |
| Postoperative pain score assessed by Visual Analog Scale (VAS) | 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. | At PACU admission and 30 minutes after PACU admission |
| Intraoperative hypotension | Incidence of MAP decrease >20% from baseline or SBP <90 mmHg | Time Frame: During surgery (up to 6 hours) |
| Postoperative nausea and vomiting | Incidence of PONV | During PACU stay (up to 2 hours after surgery) |
| Residual neuromuscular blockade assessed by train-of-four ratio | Incidence of residual neuromuscular blockade defined as train-of-four (TOF) ratio <0.7 measured quantitatively at PACU admission. | Within 15 minutes of PACU admission |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |