Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery

NCT ID: NCT05536362

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-02-28

Brief Summary

The Study Showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation.

Detailed Description

This study aimd to determine whether propofol infusion combined with clonidine and ketamine is more efficient in lowering the level of IL-8, preserving operation stability, and dropping post-operative pain and morphine intake.

When paralleled to propofol alone, TIVA employing propofol infusion along with pre-operation clonidine and ketamine is effective at preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake.

For this study, sixty contestants with ASA physical status I and II, ranging in age from 35 to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. This study excluded participants with a history of heart, renal and liver cell failure, allergic reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or mental illness. Using a computer-generated randomization list, the patients were randomly allocated into two groups (30 patients each).

The treated group(Group T),which got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine, the control group(Group C),which received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) .A third party was included in this study so neither the researchers nor the research subjects are aware of the intervention which the patients got.

Conditions

Colon Cancer; Post Operative Pain

Study Design

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

Study Groups

TCI propofol mixed with clonidine and ketamine

Patient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine

Group Type: EXPERIMENTAL

TCI Propofol Injection

Intervention Type: DRUG

To decrease postoperative pain after cancer colon surgery

TCI propofol mixed with a placebo

Control group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%)

Group Type: EXPERIMENTAL

TCI Propofol Injection

Intervention Type: DRUG

To decrease postoperative pain after cancer colon surgery

Interventions

TCI Propofol Injection

To decrease postoperative pain after cancer colon surgery

Intervention Type: DRUG

Other Intervention Names

Ketamine and clonidine

Eligibility Criteria

Inclusion Criteria

1. ASA physical status I and II

2. Patients with cancer colon

Exclusion Criteria

1. participants with a history of heart, renal and liver cell failure.

2. allergic reaction to studied drugs, and history of epilepsy,

3. hydrodynamic instability,

4. chronic pain.

5. mental illness.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nirvana Elshalakany, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

Locations

October 6 University Hospital

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Nirvana Ahmed

Identifier Type: -

Identifier Source: org_study_id