Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624166
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
incidence of hypotension [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery
Official Title  ICMJE Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery :Prospective , Randomized Double- Blinded Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: Ketamine
    patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia
    Other Name: general anesthetic
  • Drug: isotonic saline
    patients will receive 3 ml of isotonic saline after spinal anesthesia
Study Arms  ICMJE
  • Active Comparator: Ketamine
    sub- anesthetic dose of ketamine 0.5 mg/kg will be given in 3 ml volume
    Intervention: Drug: Ketamine
  • Placebo Comparator: isotonic saline
    isotonic saline 3 ml volume will be given
    Intervention: Drug: isotonic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03624166
Other Study ID Numbers  ICMJE FAMUS R 38/ 2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP