Sedation During Spinal Anesthesia

Ketamine

Brief Summary

Patients during spinal anesthesia should be sedated.

Intervention / Treatment

  • Ketamine (DRUG)
    Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
  • Midazolam (DRUG)
    Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Condition or Disease

  • Sedation During Spinal Anesthesia

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 50 Years
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

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

    Clinical Trial Dates

    Start date: Jul 14, 2018 ACTUAL
    Primary Completion: Mar 07, 2020 ACTUAL
    Completion Date: Mar 07, 2020 ACTUAL
    Study First Posted: Apr 28, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 27, 2021

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.

    Participant Groups

    • Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

    • Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Male patients aged from 18 to 40 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.

    Exclusion Criteria:

    * Age: younger than 18 or older than 40.
    * Psychatric or neurological disorders.
    * Cardiovascular disorders.
    * Coagulation disorders.
    * Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).

    Primary Outcomes

    • assessed by modified observer's assessment of alertness/sedation score

    More Details

    NCT Number: NCT03133780
    Other IDs: 42017
    Study URL: https://clinicaltrials.gov/study/NCT03133780
    Last updated: Sep 29, 2023