General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia

NCT05907811 | Completed

• 1 other identifier: 2023/5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Epidural Analgesia; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Supplemental NMBA requirement

  During surgery (up to 6 hours)

• Total intravenous fentanyl consumption

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

• Postoperative pain score assessed by Visual Analog Scale (VAS)

  At PACU admission and 30 minutes after PACU admission

• Intraoperative hypotension

  Time Frame: During surgery (up to 6 hours)

• Postoperative nausea and vomiting

  During PACU stay (up to 2 hours after surgery)

Study Arms (2)

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.

Procedure: Neuromuscular blocker usage

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.

Procedure: Neuromuscular blocker usage

Interventions

Neuromuscular blocker usage PROCEDURE

The patients were followed up, the total amount of muscle relaxant used was determined, intraoperative effects and postoperative analgesic usage

Also known as: Train of four (TOF), Blood pressure, Heart rate, Oksygen saturation, Visual analog scale

Group General anesthesia and Thoracal epidural (GAE); Group general anesthesia (GA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Arzu Esen Tekeli

Van, Turkey, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Blood Pressure; Heart Rate

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• School of Medicine Department of Anesthesiology and Reanimation

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized prospective, controlled study

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 18, 2023
• Study Start: June 5, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)