Dexmedetomidine and Remifentanil in NORA

NCT06403670 | Completed Phase 4

• 1 other identifier: NORADEX
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Comparison of the Effects of Remifentanil and Dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• Agitation-Sedation

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

  0 and 5 minutes after ERCP ends

• Hemodynamic stability

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

  5, 10, 15, 25, 35. minutes

Secondary Outcomes (3)

• Minimize drug dose

  5, 10, 15, 25, 35. minutes

• Patient comfort

  30 minutes after ERCP ends

• Rapid recovery

  30 minutes after ERCP ends

Study Arms (2)

Group Dex

ACTIVE COMPARATOR

Group Dex received 0.5 mcg/kg of dexmedetomidine IV for 10 minutes, 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.

Drug: Dexmedetomidine

Group Remi

ACTIVE COMPARATOR

Group RP received remifentanil 0.1 mcg/kg intravenously for 2 minutes, 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.

Drug: Remifentanil

Interventions

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.

Group Dex

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.

Group Remi

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1-3

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Cankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research assistant

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 8, 2024
• Study Start: December 17, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)