Thoracic Epidural AnalgesiaNCT05907811
General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia
A study testing Neuromuscular blocker usage in people with Thoracic Epidural Analgesia and Gastric Cancer, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Epidural Analgesia, Gastric Cancer
- What is being tested?
- Neuromuscular blocker usage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 5 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
See Brief Summary and study protocol sections for complete description.
- Conditions
- Thoracic Epidural Analgesia, Gastric Cancer
- Being tested
- Neuromuscular blocker usage
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular blocker usageProcedure or surgery
Also called Train of four (TOF), Blood pressure, Heart rate, Oksygen saturation
The patients were followed up, the total amount of muscle relaxant used was determined, intraoperative effects and postoperative analgesic usage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Neuromuscular blocker usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
Supplemental NMBA requirement
Number of patients requiring additional rocuronium doses
Measured: During surgery (up to 6 hours)
Total intravenous fentanyl consumption
Total intraoperative fentanyl dose (µg), including induction and supplemental boluses
Measured: 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.
Measured: At PACU admission and 30 minutes after PACU admission
Intraoperative hypotension
Incidence of MAP decrease >20% from baseline or SBP <90 mmHg
Measured: Time Frame: During surgery (up to 6 hours)
Postoperative nausea and vomiting
Incidence of PONV
Measured: 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.
Measured: Within 15 minutes of PACU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start5 Jun 2023
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Epidural AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective, controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- School of Medicine Department of Anesthesiology and Reanimation, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907811
- Sponsor's protocol ID
- 2023/5
- Status last verified
- Jun 2026
- First submitted
- 23 May 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data of participating patients will not be shared in any way.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia on Neuromuscular Block
- ClinicalTrials.gov ID
- NCT05907811
- Acronym / sponsor ID
- 2023/5
- Conditions
- Thoracic Epidural Analgesia, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See Brief Summary and study protocol sections for complete description.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized prospective, controlled study
| Arm | Type | Receives |
|---|---|---|
| Group general anesthesia (GA) | Sham comparator | Procedure: Neuromuscular blocker usageAnesthesia 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 General anesthesia and Thoracal epidural (GAE) | Experimental | Procedure: Neuromuscular blocker usageElectrodes 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular blocker usageAlso: Train of four (TOF), Blood pressure, Heart rate, Oksygen saturationThe patients were followed up, the total amount of muscle relaxant used was determined, intraoperative effects and postoperative analgesic usage | Procedure or surgery | Group General anesthesia and Thoracal epidural (GAE), Group general anesthesia (GA) |
Primary outcome
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.
6 secondary outcomes
Supplemental NMBA requirement
Time frame: During surgery (up to 6 hours)
Total intravenous fentanyl consumption
Time frame: During surgery, from anesthesia induction until skin closure (up to 6 hours)
Postoperative pain score assessed by Visual Analog Scale (VAS)
Time frame: At PACU admission and 30 minutes after PACU admission
Intraoperative hypotension
Time frame: Time Frame: During surgery (up to 6 hours)
Postoperative nausea and vomiting
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. Personal data of participating patients will not be shared in any way.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
School of Medicine Department of Anesthesiology and Reanimation study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular blocker usage in people with Thoracic Epidural Analgesia and Gastric Cancer, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.