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

It was aimed to investigate whether epidural anesthesia added to general anesthesia has an effect on neuromuscular block.

Conditions

Thoracal Epidural Block

Outcome Measures

Primary Outcomes (1)

• Neuromuscular agent

  Total neuromuscular consumption

  30 minute

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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II group
• patients
• who were scheduled for gastric ca operation were included in the study.

You may not qualify if:

• severe heart, lung, liver disease,
• kidney failure,
• bleeding diathesis,
• fever,
• infection,
• allergy to drugs to be used,
• those who refused to participate in the study,
• patients with hypothermic and acid-base disorders,
• electrolyte disorders
• antibiotics,
• anticonvulsants, Those taking antiarrhythmic, cholinesterase inhibitors will be excluded from the study.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Arzu Esen Tekeli

Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Blood Pressure; Heart Rate

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The cases were divided into 2 groups by the envelope method, and 30 subjects were included in the general anesthesia group (GA), and 30 subjects were included in the general anesthesia and thoracic epidural anesthesia group (GAE).
• Purpose: SCREENING
• 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: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)