NCT03624166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

August 7, 2018

Last Update Submit

May 18, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

    5 hours

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

isotonic saline

PLACEBO COMPARATOR

isotonic saline 3 ml volume will be given

Drug: isotonic saline

Interventions

KetamineDRUG

patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia

Also known as: general anesthetic
Ketamine
isotonic salineDRUG

patients will receive 3 ml of isotonic saline after spinal anesthesia

isotonic saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physical status American Society of Anesthesiologist(ASA) I or II. Full term pregnancy

You may not qualify if:

  • ,Pre-eclampsia.
  • Chronic hypertension.
  • Cardiovascular troubles.
  • any contraindications to spinal anesthesia as back infection , coaguolopathy , patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

KetamineAnesthetics, GeneralSodium Chloride

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 10, 2018

Study Start

February 1, 2019

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

EG(1)