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Not yet recruiting NCT07423676

Comparison Between Two Drugs in Sedation of Upper GI Endoscopy

Observational Sedation During GI Endoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sedation During GI Endoscopy. Basic parameters: 21 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ketamine - Dexmedetomidine(Ketodex) Versus Propofol -Midazolam for Sedation in Patients Undergoing Upper Gastrointestinal Endoscopy

Overview

The goal of this clinical trial is to compare time of sedation between two drugs administered to patients undergoing upper gastrointestinal endoscopy Primary outcome : Time of sedation : is the time to reach sedation score of 5 according to modified Ramsay sedation score starting from the time of injecting bolts dose of study drugs Secondary outcome : * Recovery time :is the time to reach score 2 of modified Ramsay sedation score starting from injecting bolus dose of study drugs . * Hemodynamics (MAP,HR) \& oxygen saturation * Drug side effects (nausea,vomitting,agitation) * Endoscopist satisfaction

Primary outcome measures

  • Comparison between time of sedation between ketamine Dexametomidine and propofol midazolam in sedation of GI endoscopy [Time frame: Baseline]
  • Comparison time of sedation between ketamine Dexametomidine and propofol midazolam in sedation of GI endoscopy [Time frame: Baseline]
  • Comparison of time of sedation between ketamine Dexametomidine g [Time frame: Basline]

Eligibility criteria

Inclusion criteria

  • Patient acceptance
  • Adults aged 21-60 years.
  • Both sexes
  • BMI<35 kg/m2
  • ASA physical status :I\& II
  • Patients Undergoing Gastrointestinal endoscopy
  • Duration <30mintues

Exclusion criteria

  • • Known allergy to any of the study drugs
  • Unstable Cardiovascular disease
  • Moderate to severe respiratory diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Rey JF. Sedation for upper gastrointestinal endoscopy: as much as possible, or without? Endoscopy. 1996 Mar;28(3):308-9. doi: 10.1055/s-2007-1005460. No abstract available. PMID 8781797
  • Sachdeva A, Bhalla A, Sood A, Duseja A, Gupta V. The effect of sedation during upper gastrointestinal endoscopy. Saudi J Gastroenterol. 2010 Oct-Dec;16(4):280-4. doi: 10.4103/1319-3767.70616. PMID 20871194

Identifiers

NCT: NCT07423676 · Sedation in GI endoscopy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗