Inflammation BiomarkersPhase 4NCT06784258
Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital
A Phase 4 study testing General Anesthesia combined with epidural anesthesia in people with Inflammation Biomarkers and Quality of Recovery (QoR-15), run by Udayana University at 1 site in Indonesia.
Trial summary
Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammation Biomarkers, Quality of Recovery (QoR-15), Visual Analog Pain Scale
- What is being tested?
- General Anesthesia combined with epidural anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Dec 2024to 28 Jan 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients aged 18 - 65 years
- Patients with ASA physical status I - III
Who cannot join
- Patients with contraindications to regional anesthesia
- Patients with mental disorders or psychiatric disorders
- The patient has a history of allergy to the local anesthetic used.
- The patient or family refuses to take part in the study
- BMI > 30 Kg/m2
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Anesthesiology and Intensive Therapy Udayana University
Denpasar, Bali
About this study
Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery.
Objectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.
Read the detailed description
Patients will be divided into 2 groups: Group P (treatment) and Group K (control).
Before anesthesia, 2-3 mL of blood will be collected by the researcher from patients in both groups using a red tube.
Patients in the control group will undergo conventional general anesthesia. Patients in the treatment group will undergo conventional general anesthesia combined with epidural anesthesia. Patients will be administered 0.25% Bupivacaine local anesthetic incrementally until the desired volume is achieved based on the targeted segmental block height.
Six hours postoperatively, 2-3 mL of blood will be collected, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively.
- Being tested
- General Anesthesia (control group), General Anesthesia combined with epidural anesthesia
- Keywords
- epidural anesthesia, interleukin 6, postoperative pain, colorectal cancer, regional anesthesia, Quality of Recovery-15
- Medical subject headings
- Pain, Postoperative, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia (control group)Procedure or surgery
The patient will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/kg BB. After that the patient will be intubated
General Anesthesia combined with epidural anesthesiaProcedure or surgery
The patient will undergo epidural anesthesia first with an epidural catheter inserted through a Tuohy needle and ensuring that the length of the multihole epidural catheter that enters the epidural space is 5-6 cm. After that, the patient underwent conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/ kg BW. After that the patient will be intubated. The patient will be given local anesthesia Bupivacaine 0.25% in increments to the desired volume according to the desired height of the segmental block. Local anesthetic medication will be given intermittently every 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Control Group : Conventinal General Anesthesia | Active comparator | Patients in the control group will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patient will be given opioid analgesics (Morphine dose 0.5-1 mg/hour given continuously or Fentanyl dose 10-50/hour mcg given continuously), Ketorolac 30 mg every 8 hours intravenously and Paracetamol 500 mg every 6 hours orally Receives: Procedure: General Anesthesia (control group) |
| Experimental Group : Conventinal General Anesthesia Combine with Epidural Anesthesia | Experimental | Patients in the experimental group will undergo conventional general anesthesia combine with epidural anesthesia. The patient will undergo epidural anesthesia first with an epidural catheter, the general anesthesia with intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patietn will be given Epidural analgesic Bupivacaine 0.1% + Morphine 0.5 mg volume 10 mL every 12 hours, Ketorolac 30 mg every 8 hours + Paracetamol 500 mg every 6 hours orally Receives: Procedure: General Anesthesia combined with epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce Interleukin 6 differences
Interleukin 6 will be collected before surgery and 6 hours after surgery by the anesthesiologist in the Operating theatre.
Measured: before surgery and 6 hours after surgery
Secondary outcomes (2)
Reduce VAS pain scale
VAS scale will be collected by the anesthesiologist in charge of the patient 24 hours after surgery
Measured: 24 Hours
Increase Quality of Recovery - 15
QOR-15 score will be collected by the anesthesiologist in charge of the patient 24 hours after surgery
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start28 Dec 2024
- Primary completion28 Jan 2025 (estimated)
- Study completion28 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation BiomarkersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Colorectal patient undergoing elective surgery
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmy Wongkar, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784258
- Sponsor's protocol ID
- 3005/UN14.2.2.VII.14/LT/2024
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital
- ClinicalTrials.gov ID
- NCT06784258
- Acronym / sponsor ID
- 3005/UN14.2.2.VII.14/LT/2024
- Keywords
- epidural anesthesia, interleukin 6, postoperative pain, colorectal cancer, regional anesthesia, Quality of Recovery-15
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 28 Jan 2025 (estimated)
- Study completion
- 28 Jan 2025 (estimated)
- First posted
- 20 Jan 2025 (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.
Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery.
Objectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.
Detailed description
Patients will be divided into 2 groups: Group P (treatment) and Group K (control).
Before anesthesia, 2-3 mL of blood will be collected by the researcher from patients in both groups using a red tube.
Patients in the control group will undergo conventional general anesthesia. Patients in the treatment group will undergo conventional general anesthesia combined with epidural anesthesia. Patients will be administered 0.25% Bupivacaine local anesthetic incrementally until the desired volume is achieved based on the targeted segmental block height.
Six hours postoperatively, 2-3 mL of blood will be collected, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Colorectal patient undergoing elective surgery
| Arm | Type | Receives |
|---|---|---|
| Control Group : Conventinal General Anesthesia | Active comparator | Procedure: General Anesthesia (control group)Patients in the control group will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patient will be given opioid analgesics (Morphine dose 0.5-1 mg/hour given continuously or Fentanyl dose 10-50/hour mcg given continuously), Ketorolac 30 mg every 8 hours intravenously and Paracetamol 500 mg every 6 hours orally |
| Experimental Group : Conventinal General Anesthesia Combine with Epidural Anesthesia | Experimental | Procedure: General Anesthesia combined with epidural anesthesiaPatients in the experimental group will undergo conventional general anesthesia combine with epidural anesthesia. The patient will undergo epidural anesthesia first with an epidural catheter, the general anesthesia with intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patietn will be given Epidural analgesic Bupivacaine 0.1% + Morphine 0.5 mg volume 10 mL every 12 hours, Ketorolac 30 mg every 8 hours + Paracetamol 500 mg every 6 hours orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 - 65 years
- Patients with ASA physical status I - III
Key exclusion criteria (5 listed)
- Patients with contraindications to regional anesthesia
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 |
|---|---|---|
| General Anesthesia (control group)The patient will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/kg BB. After that the patient will be intubated | Procedure or surgery | Control Group : Conventinal General Anesthesia |
| General Anesthesia combined with epidural anesthesiaThe patient will undergo epidural anesthesia first with an epidural catheter inserted through a Tuohy needle and ensuring that the length of the multihole epidural catheter that enters the epidural space is 5-6 cm. After that, the patient underwent conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/ kg BW. After that the patient will be intubated. The patient will be given local anesthesia Bupivacaine 0.25% in increments to the desired volume according to the desired height of the segmental block. Local anesthetic medication will be given intermittently every 2 hours | Procedure or surgery | Experimental Group : Conventinal General Anesthesia Combine with Epidural Anesthesia |
Primary outcome
Reduce Interleukin 6 differences
Time frame: before surgery and 6 hours after surgery
Interleukin 6 will be collected before surgery and 6 hours after surgery by the anesthesiologist in the Operating theatre.
2 secondary outcomes
Reduce VAS pain scale
Time frame: 24 Hours
Increase Quality of Recovery - 15
Time frame: 24 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing General Anesthesia combined with epidural anesthesia in people with Inflammation Biomarkers and Quality of Recovery (QoR-15), run by Udayana University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. 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 Indonesia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Reduce Interleukin 6 differences (time frame: before surgery and 6 hours after surgery). 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 20 Jan 2025.