Abdominoplasty Under Spinal Anesthesia

Ketamine

Brief Summary

100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia

Intervention / Treatment

  • Propofol 10 Mg/mL Intravenous Emulsion (DRUG)
    when spinal anesthesia is not satisfactory intervention drugs are used

Condition or Disease

  • Spinal Anesthesia Suitability for Abdominoplasty

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 200 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Jan 30, 2017 ACTUAL
    Primary Completion: Apr 30, 2018 ACTUAL
    Completion Date: Dec 31, 2018 ACTUAL
    Study First Posted: Jan 18, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 17, 2019

    Sponsors / Collaborators

    Lead Sponsor: Ain Shams University
    Responsible Party: N/A

    Location

    Cairo, Egypt

    200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.

    Participant Groups

    • Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia.

    • General anesthesia for abdominoplasty

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * All patients between 18-55 years
    * ASA I and II

    Exclusion Criteria:

    * BMI more than 35 years
    * Contraindications for regional anesthesia

    Primary Outcomes

    • Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt

    • Satisfaction score with maximum score is fully satisfied and least is completely disagree

    More Details

    NCT Number: NCT03810547
    Other IDs: ASUH1011/17
    Study URL: https://clinicaltrials.gov/study/NCT03810547
    Last updated: Sep 29, 2023