Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery

Ketamine

Brief Summary

.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.

Intervention / Treatment

  • Ketamine Hydrochloride (DRUG)
    intravenous ketamine infusion intraoperatively
  • Normal saline (DRUG)
    intravenous normal saline infusion intraoperatively

Condition or Disease

  • Postoperative Analgesia

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    SINGLE:
    • Investigator

    Clinical Trial Dates

    Start date: Dec 01, 2017 ESTIMATED
    Primary Completion: Jan 01, 2019 ESTIMATED
    Completion Date: Mar 01, 2019 ESTIMATED
    Study First Posted: Nov 17, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 13, 2017

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.

    II- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.

    Participant Groups

    • intravenous ketamine infusion in the intraoperative period

    • intravenous normal saline infusion in the intraoperative period

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * - Patient's status ASA status-I and II.
    * Patients age above 18 years old.
    * Patients scheduled for intestinal surgery.

    Exclusion Criteria:

    * Patient refusal.
    * Patients with known allergy to ketamine or morphine.
    * Patients with significant hepatic dysfunction.
    * Patients with severe renal disease.
    * Significant Heart disease.
    * Patients with chronic pain.
    * Regular use analgesics, antidepressants or opioids in last 2 months.
    * Any known convulsive disorder.
    * Morbid obesity (BMI\>35).
    * Patients with autoimmune disease
    * Patients on corticosteroid therapy
    * Pregnancy.
    * Breast feeding.
    * Woman under hormonal treatment.
    * Oral disease.

    Primary Outcomes

    • IV PCA

    Secondary Outcomes

    • salivary

    • salivary

    More Details

    NCT Number: NCT03344393
    Other IDs: 17200147
    Study URL: https://clinicaltrials.gov/study/NCT03344393
    Last updated: Sep 29, 2023