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Completed

NCT Number: NCT04906772

Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients

We aim to compare the response to ketamine/dexmedetomidine and ketamine/propofol combinations used in hepatic patients with child-Pugh classification (class A), and early (class B) undergoing UGIE.

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Key information

Conditions

Anesthesia; Reaction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of medicine, Ain-Shams university

Cairo, Egypt

About this study

70 Patients will be randomly allocated into two groups; Group (KD): Ketamine/dexmedetomidine (35 patients), will receive IV ketamine 0.25mg/kg and dexmedetomidine1µg/kg over 10 min as loading followed by dexmedetomidine infusion with a rate of 0.5µg/kg/hr and Group (KP): ketamine/propofol (35 patients) will receive IV ketamine 0.25 mg/kg loading and propofol 1 mg/kg over 10 min followed by propofol infusion with a rate of 0.5 mg/kg/hr as a control group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • hepatic patients with child-Pugh classification (class A), and (class B)
  • American Society of Anesthesiologists physical status II, III
  • aged 18 to 60 years
  • scheduled for elective Upper gastro-intestinal endoscopy.

Exclusion criteria

  • emergency gastro-intestinal endoscopy.
  • patients with severe hepatic disorder (Child C) ,
  • chronic neuro-psychiatric disorder,
  • history of neuro-psychiatric drug intake,
  • severe cardiovascular diseases,
  • pregnancy,
  • history of drug abuse, and
  • history of allergy to any of the used drugs in the study

Treatment and study plan

Dexmedetomidine

Drug

participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.

Other names: ketamine

Propofol

Drug

participants received loading of ketamine 1 mg/kg and propofol 1mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25µg/kg/hr dexmedetomidine throughout the procedure.

Other names: ketamine

Primary outcomes

  1. induction time

    Time frame: after 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reached

    Time to reach target Ramsay Sedation Score ≥ 3

  2. Recovery time

    Time frame: after 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening

    time from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening

Sponsors and collaborators

Lead sponsor

Tamer Nabil Abdelrahman

Other

Registry information

Official study title

Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Jan 31, 2024

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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