General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia

Yuzuncu Yil University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Thoracic Epidural Analgesia Gastric Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Supplemental NMBA requirement

Number of patients requiring additional rocuronium doses

Time frame: During surgery (up to 6 hours)

Total intravenous fentanyl consumption

Total intraoperative fentanyl dose (µg), including induction and supplemental boluses

Time frame: 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.

Time frame: At PACU admission and 30 minutes after PACU admission

Intraoperative hypotension

Incidence of MAP decrease \>20% from baseline or SBP \<90 mmHg

Time frame: Time Frame: During surgery (up to 6 hours)

Postoperative nausea and vomiting

Incidence of PONV

Time frame: 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.

Time frame: Within 15 minutes of PACU admission