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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Thoracic Epidural Analgesia
• Intervention / Treatment: Procedure: Neuromuscular blocker usage

Detailed Description

See Brief Summary and study protocol sections for complete description.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Van, Turkey, Turkey (Türkiye), 65100
      • Arzu Esen Tekeli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group general anesthesia (GA); 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.	Procedure: Neuromuscular blocker usage; The patients were followed up, the total amount of muscle relaxant used was determined, intraoperative effects and postoperative analgesic usage; Other Names: Heart rate; Blood pressure; Train of four (TOF); Oksygen saturation; Visual analog scale
Experimental: Group General anesthesia and Thoracal epidural (GAE); 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.	Procedure: Neuromuscular blocker usage; The patients were followed up, the total amount of muscle relaxant used was determined, intraoperative effects and postoperative analgesic usage; Other Names: Heart rate; Blood pressure; Train of four (TOF); Oksygen saturation; Visual analog scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	During surgery, from anesthesia induction until skin closure (up to 6 hours)
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
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

Collaborators and Investigators

• Sponsor: Yuzuncu Yil University
• Investigators: Study Chair: School of Medicine Department of Anesthesiology and Reanimation, Yuzuncu Yil University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Blood Pressure; Heart Rate
• Other Study ID Numbers: 2023/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Personal data of participating patients will not be shared in any way.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No