General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia

NCT ID: NCT05907811

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-03-02

Brief Summary

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

Detailed Description

The study was carried out with patients who were evaluated preoperatively in the Department of Anesthesiology and Reanimation, Department of Anesthesiology, Faculty of Medicine, Yuzuncu Yıl University. Sixty ASA I-II group patients, aged between 18-65 and scheduled for gastric ca operation, were included in the study. 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 such as hypokalemia, hypocalcemia, antibiotics, anticonvulsants, Those taking antiarrhythmic and cholinesterase inhibitors were excluded from the study.

The cases were divided into 2 groups by the envelope method, 30 people will be included in the general anesthesia group (GA), and 30 people will be included in the general anesthesia and thoracic epidural anesthesia group (GAE). After the patients who did not receive premedication were taken to the operating room, standard monitoring was provided with ECG, non-invasive arterial pressure, peripheral oxygen saturation. Peripheral vein cannulation was performed with a 20 gauge i.v. catheter, and a 4 mL/kg 0.9% NaCl infusion was started. In Group GAE, after preoperative asepsis was achieved, cutaneous-subcutaneous local anesthetic was infiltrated through the T7-9 space. The epidural space was determined by the loss of resistance method with a 16 gauge Tuohy epidural needle, and an 18 gauge epidural catheter was placed in the epidural space at a 4 cm angle in the cranial direction. The location of the catheter was confirmed by applying a test dose of 3 mL 2% lidocaine containing 5μ/ml adrenaline. After 5 minutes, 5 ml of 0.125% bupivacaine was given and the patient was placed in the supine position immediately afterwards. 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 Train of four (TOF) value was 0, patients were intubated with an endotracheal tube (7-7.5 endotracheal tube (ETT) for women, 8-8.5 ETT for men). In maintenance, desflurane at 8% concentration was applied in a mixture of 50% O2 + 50% air. The time to reach 25% of the TOF value for both groups was noted. 0.1mg/kg rocuronium was added to patients who reached 0.25. The number of additional muscle relaxant requirements was recorded. In the GAE group, 5 ml of epidural drug was given every hour. In the GA group, 0.05mg/kg morphine was given 30 minutes before the end of the operation. Considering the time it took for the TOF value to reach 70%, the inhaler anesthetics were terminated and the patients with a TOF value of 90% were extubated.

Conditions

Thoracal Epidural Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Neuromuscular blocker usage

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Neuromuscular blocker usage

Intervention Type: PROCEDURE

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

Interventions

Neuromuscular blocker usage

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

Intervention Type: PROCEDURE

Other Intervention Names

Train of four (TOF); Blood pressure; Heart rate; Oksygen saturation; Visual analog scale

Eligibility Criteria

Inclusion Criteria

• ASA I-II group
• 60 patients
• 18-65 who were scheduled for gastric ca operation were included in the study.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Arzu Esen Tekeli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

School of Medicine Department of Anesthesiology and Reanimation

Role: STUDY_CHAIR

Yuzuncu Yıl University

Locations

Arzu Esen Tekeli

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/5

Identifier Type: -

Identifier Source: org_study_id