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NCT Number: NCT05907811

General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia

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.

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Key information

Conditions

Thoracic Epidural Analgesia Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arzu Esen Tekeli

Van, Turkey, 65100, Turkey (Türkiye)

About this study

See Brief Summary and study protocol sections for complete description.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular blocker usage

Procedure

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

Other names: Train of four (TOF), Blood pressure, Heart rate, Oksygen saturation, Visual analog scale

Primary outcomes

  1. Duration of recovery from TOF 25% to TOF 90% (DUR25-90)

    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)

    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 outcomes

  1. Supplemental NMBA requirement

    Time frame: During surgery (up to 6 hours)

    Number of patients requiring additional rocuronium doses

  2. Total intravenous fentanyl consumption

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

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

  3. Postoperative pain score assessed by Visual Analog Scale (VAS)

    Time frame: 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.

  4. Intraoperative hypotension

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

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

  5. Postoperative nausea and vomiting

    Time frame: During PACU stay (up to 2 hours after surgery)

    Incidence of PONV

  6. Residual neuromuscular blockade assessed by train-of-four ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

The Effect of General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia on Neuromuscular Block

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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