Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy

NCT06185127 | Completed Phase 3

• 1 other identifier: DKvFM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. This study aimed to compare the standard recommended combination of midazolam-fentanyl (MF) with that of dexmedetomidine-ketamine (DK) for patient sedation during FB. Patients subjected to FB were randomly assigned to a DK (n=25) and an MF group (n=25). The primary outcome was the rate of critical desaturation events (arterial oxygen saturation \<80% with nasal oxygen supply 2 L/min). Secondary outcomes included sedation depth, hemodynamic complications, adverse events, and patient and bronchoscopist satisfaction.

Conditions

Lung Diseases; Diagnosis; Anesthesia

Outcome Measures

Primary Outcomes (20)

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 10 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 20 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 30 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 40 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 50 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 60 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 70 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 80 of procedure

• Depth of sedation Ramsay

  Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)

  Minute 90 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 10 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 20 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 30 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 40 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 50 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 60 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 70 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 80 of procedure

• Depth of sedation Riker

  Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)

  Minute 90 of procedure

• Bronchoscopist satisfaction

  Bronchoscopist satisfaction was measured with a Likert-scale tool answering the question "How satisfied are you with both the ease and outcome of the procedure?" as follows: 1 = not satisfied at all; 2 = somewhat satisfied; 3 = more satisfied with the procedural outcome; 4 = mostly satisfied with the outcome and somewhat with procedural ease; 5 = exceptionally satisfied with both procedural outcome and ease.

  1 hour after the end of the procedure

• Patient satisfaction

  Patient satisfaction was evaluated by a short, custom-made questionnaire that included the following questions: 1) I was satisfied with the sedation administered for the procedure, 2) I felt pain and/or discomfort beyond my tolerance during the procedure, 3) I believe my needs were met during the procedure 4) I felt pain and discomfort after the procedure, 5) I would be willing to undergo a second procedure if the first did not yield adequate results. The responses were measured in a Likert scale format with values 1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 =strongly agree. Questions 2 and 4 were scored reversely.

  24 hours after bronchoscopy

Study Arms (2)

DK group

EXPERIMENTAL

Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given.

Drug: Dexmedetomidine; Drug: Ketamine

MF group

ACTIVE COMPARATOR

Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered.

Drug: Midazolam; Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion).

Also known as: Dexmedetomidine administration

DK group

Ketamine DRUG

A bolus dose of 50 mg ketamine dissolved in 10 ml saline was given 15 minutes after Dexmedetomidine initiation.

Also known as: Ketamine administration

DK group

Midazolam DRUG

Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam were administered.

Also known as: Midazolam administration

MF group

Fentanyl DRUG

Bolus doses of fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 150 μg of fentanyl were administered.

Also known as: Fentanyl administration

MF group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for flexible bronchoscopy at the Naval Hospital of Athens
• Written informed consent

You may not qualify if:

• known or suspected allergy to any of the study drugs
• renal impairment (serum creatinine \> 2 mg/dL)
• hepatic impairment (liver enzymes \> 2 times the upper limit of normal)
• seizure disorders
• history of psychosis or bipolar disorder
• hemodynamic instability (heart rate - HR \< 50 bpm or systolic blood pressure - SBP \< 90 mmHg)
• critically ill patients.

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Naval Hospital

Athens, Attica, 15561, Greece

Location

MeSH Terms

Conditions

Lung Diseases; Disease

Interventions

Dexmedetomidine; Ketamine; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines

Study Officials

• Sotirios Fouzas, MD, PhD

  University of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor of Pediatric Respiratory Medicine

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: September 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: August 31, 2020
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)