Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery

Phase 1

Completed

• Conditions: Colon Cancer; Post Operative Pain
• Interventions: Drug: TCI Propofol Injection

• Registration Number: NCT05536362
• Lead Sponsor: Egymedicalpedia

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.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-02-28
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCI propofol mixed with a placebo	TCI Propofol Injection	Control group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%)
TCI propofol mixed with clonidine and ketamine	TCI Propofol Injection	Patient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine

Primary Outcome Measures

Name	Time	Method
Measurement of Post-operative Pain	24-hour analgesic after surgery	Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).

Trial Locations

Locations (1)

October 6 University Hospital; 🇪🇬 Giza, Cairo, Egypt