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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

Study Description
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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
Anesthesia Drug: Ketamine Drug: isotonic saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2019
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624166


Locations
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Egypt
Ain Shams University hospitals
Cairo, Egypt, 11591
Sponsors and Collaborators
Ain Shams University
More Information
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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: August 10, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Ketamine
Anesthetics
Anesthetics, General
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action