NCT04597268

Brief Summary

This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

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

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

October 15, 2020

Last Update Submit

January 8, 2023

Conditions

Sedation and Analgesia

Outcome Measures

Primary Outcomes (1)

  • Ramsy sedation score (RSS)

    time to achievement of Ramsy sedation score (RSS) 3-4, Ramsy sedation scale score from 1 to 6, 1 meaning anxious and 6 meaning no response to stimulus

    3 to 6 months

Study Arms (3)

dexmedetomidine

EXPERIMENTAL

IV dexmedetomidine

Drug: Dexmedetomidine

ketamine

EXPERIMENTAL

IV ketamine

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

IV midazolam

Drug: Midazolam

Interventions

DexmedetomidineDRUG

intravenous dexmedetomidine 1 mic/kg

Also known as: propofol- dexmedetomidine
dexmedetomidine
KetamineDRUG

ketamine 1mg/kg

Also known as: propofol- ketamine
ketamine
MidazolamDRUG

midazolam 0.05 mg/kg

Also known as: propofol- midazolam
Midazolam

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for gastrointestinal endoscopic procedures
  • ≥ Age 18 years
  • ASA I-II

You may not qualify if:

  • Allergy to any of the used drugs
  • impaired renal or liver functions
  • hypertensive patients
  • patients with cardiovascular
  • cerebrovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

DexmedetomidineKetamineMidazolam

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Walaa Y Elsabeeny, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Nahla Y Shehab, MD

    Lecturer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and pain management

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

November 1, 2020

Primary Completion

December 15, 2022

Study Completion

December 30, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Data available upon reasonable request through contacting the corresponding author

Locations

EG(1)