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Completed

NCT Number: NCT04597268

Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

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.

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Key information

Conditions

Sedation and Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walaa Y Elsabeeny

Cairo, 11796, Egypt

About this study

Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dexmedetomidine

Drug

intravenous dexmedetomidine 1 mic/kg

Other names: propofol- dexmedetomidine

ketamine

Drug

ketamine 1mg/kg

Other names: propofol- ketamine

midazolam

Drug

midazolam 0.05 mg/kg

Other names: propofol- midazolam

Primary outcomes

  1. Ramsy sedation score (RSS)

    Time frame: 3 to 6 months

    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

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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