Skip to main content
OpenTrials
Completed

NCT Number: NCT06403670

Dexmedetomidine and Remifentanil in NORA

Endoscopic retrograde cholangiopancreatography (ERCP) procedure is frequently encountered in non-operating room anesthesia applications (NORA). It is a procedure that requires deep sedation and analgesia in terms of gastroenterologist and patient comfort. Dexmedetomidine, which is increasingly used in NORA applications, comes to the fore because it does not cause respiratory depression, reduces the stress response, and provides hemodynamic stability. This study aims to compare the effects of dexmedetomidine-propofol (DP) and remifentanil-propofol (RP) combinations on hemodynamic stability, rapid recovery, and patient comfort in patients who underwent ERCP.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Comparison of the Effects of Remifentanil and Dexmedetomidine

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baskent University Ankara Hospital

Ankara, Cankaya, 06490, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-ASA 1-3

Exclusion criteria

  • Neurological disease,
  • Psychiatric disease,
  • Coronary artery disease,
  • Long-term sedative drug use,
  • Pregnant patients,
  • Known allergy to planned drugs

Treatment and study plan

Dexmedetomidine

Drug

Group DP received 0.5 mcg/kg of dexmedetomidine IV for 30 seconds, then dexmedetomidine infusion was started at 0.1-0.7 mcg/kg/h. Propofol 1 mg/kg was administered after waiting for 5 minutes for adequate sedation to develop due to dexmedetomidine's delayed onset of action.

Remifentanil

Drug

Group RP received remifentanil 0.1 mcg/kg intravenously for 30 seconds, then remifentanil infusion was started at 0.01-0.1 mcg/kg/min. After waiting 2 minutes to develop a sufficient sedation level, 1 mg/kg of propofol was given.

Primary outcomes

  1. Agitation-Sedation

    Time frame: 0 and 5 minutes after ERCP ends

    It will be evaluated with a Richmond Agitation-Sedation Scale.

  2. Hemodynamic stability

    Time frame: 5, 10, 15, 25, 35. minutes

    Mean arterial pressure with non-invasive blood pressure monitoring (mmHg)

Secondary outcomes

  1. Minimize drug dose

    Time frame: 5, 10, 15, 25, 35. minutes

    Amounts of medication administered throughout the procedure period will be collected.

  2. Patient comfort

    Time frame: 30 minutes after ERCP ends

    It will be evaluated by nausea-vomiting and survey.

  3. Rapid recovery

    Time frame: 30 minutes after ERCP ends

    It will be evaluated with a Modified Aldrete Score.

Sponsors and collaborators

Lead sponsor

Baskent University Ankara Hospital

Other

Registry information

Official study title

The Effects of Dexmedetomidine and Remifentanil on Sedation and Comfort in Non-Operating Room Anesthesia: A Randomized, Double-blind, Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 8, 2024
Registry last updated
May 8, 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.