Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines

Brief Summary

This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.

Intervention / Treatment

  • Ketamine (DRUG)
    patients receive local anesthetic wound infiltration with 1 mg /kg ketamine
  • Dexmedetomidine (DRUG)
    patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine
  • Bupivacaine (DRUG)
    patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline

Condition or Disease

  • Endometrial Adenocarcinoma

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2017 ACTUAL
    Primary Completion: Aug 01, 2018 ACTUAL
    Completion Date: Sep 01, 2018 ACTUAL
    Study First Posted: May 23, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 19, 2020

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * ASA I-II patients
    * age range (18-60) years,
    * weight (50- 90) kg

    Exclusion Criteria:

    * allergy to study drugs
    * significant cardiac disease
    * respiratory disease
    * renal disease
    * hepatic disease

    Primary Outcomes
    • severity of pain at rest and on coughing will be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 = worst imaginable pain)

    Secondary Outcomes
    • sedation by using sedation score

    More Details

    NCT Number: NCT03164590
    Other IDs: 388
    Study URL: https://clinicaltrials.gov/study/NCT03164590
    Last updated: Sep 29, 2023