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

NCT06784258 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 3005/UN14.2.2.VII.14/LT/2024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. Objectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.

Conditions

Inflammation Biomarkers; Quality of Recovery (QoR-15); Visual Analog Pain Scale

Keywords

epidural anesthesia; interleukin 6; postoperative pain; colorectal cancer; regional anesthesia; Quality of Recovery-15

Outcome Measures

Primary Outcomes (1)

• Reduce Interleukin 6 differences

  Interleukin 6 will be collected before surgery and 6 hours after surgery by the anesthesiologist in the Operating theatre.

  before surgery and 6 hours after surgery

Secondary Outcomes (2)

• Reduce VAS pain scale

  24 Hours

• Increase Quality of Recovery - 15

  24 Hours

Study Arms (2)

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

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

Procedure: General Anesthesia combined with epidural anesthesia

Interventions

General Anesthesia (control group) PROCEDURE

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

Control Group : Conventinal General Anesthesia

General Anesthesia combined with epidural anesthesia PROCEDURE

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

Experimental Group : Conventinal General Anesthesia Combine with Epidural Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 - 65 years
• Patients with ASA physical status I - III

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Anesthesiology and Intensive Therapy Udayana University

Denpasar, Bali, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative; Colorectal Neoplasms

Interventions

Anesthesia, General; Control Groups; Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Anesthesia, Conduction

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Colorectal patient undergoing elective surgery

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: December 28, 2024
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: January 20, 2025

Record last verified: 2024-12

Locations

ID (1)