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Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03624166
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
27.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of sub anesthetic dose of ketamine on vasopressor (Ephedrine) requirement to prevent maternal hypotension after spinal anesthesia in caesarean section.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery :Prospective , Randomized Double- Blinded Study
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ketamine

sub- anesthetic dose of ketamine 0.5 mg/kg will be given in 3 ml volume

Drug: Ketamine
patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia
Other Names:
  • general anesthetic

    		•
    Placebo Comparator: isotonic saline

    isotonic saline 3 ml volume will be given

    Drug: isotonic saline
    patients will receive 3 ml of isotonic saline after spinal anesthesia

    Outcome Measures

    Primary Outcome Measures

    1. incidence of hypotension [5 hours]

      after spinal anesthesia sub- anesthetic dose of ketamine will be given and blood pressure will be recorded every 2 minutes till delivery , every 5 minutes till end of surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Physical status American Society of Anesthesiologist(ASA) I or II. Full term pregnancy
    Exclusion Criteria:

    • ,Pre-eclampsia.

    • Chronic hypertension.

    • Cardiovascular troubles.

    • any contraindications to spinal anesthesia as back infection , coaguolopathy , patient refusal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University hospitals Cairo Egypt 11591

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amin Mohammed Alansary Amin Ahmed Helwa, Assistant Professor, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03624166
    Other Study ID Numbers:
    • FAMUS R 38/ 2018
    First Posted:
    Aug 10, 2018
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypotension
    Ketamine
    Anesthetics
    Anesthetics, General

    Study Results

    No Results Posted as of May 19, 2020