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Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery

Sponsor
Egymedicalpedia (Industry)
Overall Status
Completed
CT.gov ID
NCT05536362
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12.9
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TCI Propofol Injection
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intakepreserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Consequences of Co-Administration of Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group T

This is the patient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine

Drug: TCI Propofol Injection
To decrease postoperative pain after cancer colon surgery
Other Names:
  • Ketamine and clonidine

    		•
    Experimental: Group C

    this is the control group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%)

    Drug: TCI Propofol Injection
    To decrease postoperative pain after cancer colon surgery
    Other Names:
  • Ketamine and clonidine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 October 6 University Hospital Giza Cairo Egypt 11311

    Sponsors and Collaborators

    • Egymedicalpedia

    Investigators

    • Principal Investigator: Nirvana Elshalakany, Professor, Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Egymedicalpedia
    ClinicalTrials.gov Identifier:
    NCT05536362
    Other Study ID Numbers:
    • Nirvana Ahmed
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colonic Neoplasms
    Pain, Postoperative
    Clonidine
    Ketamine
    Propofol

    Study Results

    No Results Posted as of Sep 10, 2022