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

Primary Purpose

Anesthesia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
isotonic saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine

isotonic saline

Arm Description

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

isotonic saline 3 ml volume will be given

Outcomes

Primary Outcome Measures

incidence of hypotension
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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2018
Last Updated
May 18, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03624166
Brief Title
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery
Official Title
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery :Prospective , Randomized Double- Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
sub- anesthetic dose of ketamine 0.5 mg/kg will be given in 3 ml volume
Arm Title
isotonic saline
Arm Type
Placebo Comparator
Arm Description
isotonic saline 3 ml volume will be given
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
general anesthetic
Intervention Description
patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
isotonic saline
Intervention Description
patients will receive 3 ml of isotonic saline after spinal anesthesia
Primary Outcome Measure Information:
Title
incidence of hypotension
Description
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
Time Frame
5 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

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

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