Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon

NCT ID: NCT04518579

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2020-08-01

Brief Summary

Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.

Conditions

Immunity Factors in Cancer Colon Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group (EP)

Group (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)

Group Type: ACTIVE_COMPARATOR

thoracic epidural

Intervention Type: PROCEDURE

undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections

Group (EH)

Group (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)

Group Type: ACTIVE_COMPARATOR

thoracic epidural

Intervention Type: PROCEDURE

undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections

Interventions

thoracic epidural

undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections

Intervention Type: PROCEDURE

Other Intervention Names

thoracic epidural catheter

Eligibility Criteria

Inclusion Criteria

• Age 20-70 yrs.
• ASA class I and II
• Elective open surgery for non-metastatic cancer colon stage I,II

Exclusion Criteria

• Patient refusal
• Known allergy to the study medications
• Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids)
• Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Egypt Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Bahaa Gamal

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

samy ab amr, professor

Role: STUDY_CHAIR

dean of SECI

Locations

South Egypt Cancer Institute

Asyut, , Egypt

Countries

Egypt

Other Identifiers

375

Identifier Type: -

Identifier Source: org_study_id