General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia

June 2, 2026 updated by: Arzu Esen Tekeli, Yuzuncu Yil University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

See Brief Summary and study protocol sections for complete description.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Supplemental NMBA requirement
Time Frame: During surgery (up to 6 hours)
Number of patients requiring additional rocuronium doses
During surgery (up to 6 hours)
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
During surgery, from anesthesia induction until skin closure (up to 6 hours)
Intraoperative hypotension
Time Frame: Time Frame: During surgery (up to 6 hours)
Incidence of MAP decrease >20% from baseline or SBP <90 mmHg
Time Frame: During surgery (up to 6 hours)
Postoperative nausea and vomiting
Time Frame: During PACU stay (up to 2 hours after surgery)
Incidence of PONV
During PACU stay (up to 2 hours after surgery)
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.
Within 15 minutes of PACU admission
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.
At PACU admission and 30 minutes after PACU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yil University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: School of Medicine Department of Anesthesiology and Reanimation, Yuzuncu Yil University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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