NCT03133780

Brief Summary

Patients during spinal anesthesia should be sedated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 14, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2020

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

April 26, 2017

Last Update Submit

February 20, 2024

Conditions

Sedation During Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score

    assessed by modified observer's assessment of alertness/sedation score

    90 minutes after spinal anesthesia

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Drug: Midazolam

Interventions

KetamineDRUG

Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Also known as: Ketalar
Ketamine
MidazolamDRUG

Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Also known as: dormicum
Midazolam

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.

You may not qualify if:

  • Age: younger than 18 or older than 50.
  • Psychatric or neurological disorders.
  • Cardiovascular disorders.
  • Coagulation disorders.
  • Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Assuit University

Asyut, Asyut Governorate, 71516, Egypt

Location

MeSH Terms

Interventions

KetamineMidazolam

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Seham M Moeen, MD

    Assiut Univerisity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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
Principal Investigator

Study Record Dates

First Submitted

April 26, 2017

First Posted

April 28, 2017

Study Start

July 14, 2018

Primary Completion

March 7, 2020

Study Completion

March 7, 2020

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

EG(1)