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Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy

NCT06181188 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-12-26

No results posted yet for this study

Summary

In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Pulmonary Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting for bronchoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either 1 mg of midazolam and ketamine 0.25 to 0.5 mg/kg loading dose with subsequent doses of 10-20 mg IV or standard fentanyl and midazolam in 25mcg and 1mg increments respectively for moderate sedation during their procedure. The primary outcome will be patient satisfaction, which will be measured a using patient clinical satisfaction form. A number of secondary outcomes will include the following: (1) provider satisfaction (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to scope removal from the trachea (4) the time from sedation to discharge (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (5) total dose of medications given (including midazolam, fentanyl, and ketamine), (6) adverse events, (7) vital signs, (8) and the need for additional medications, in particular reversal agents.

Conditions

  • Conscious Sedation
  • Patient Satisfaction
  • Ketamine

Interventions

DRUG

Ketamine

Patients will receive a combination of ketamine and midazolam for conscious sedation

DRUG

Midazolam

Patients will receive 1mg of midazolam regardless of which arm they are in and my be given 1mg doses for added sedation as needed every 3-5 minutes

DRUG

Fentanyl

Patients randomized to the midazolam and fentanyl arm will receive 25mcg incremental doses for procedural sedation

Sponsors & Collaborators

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Jess Anderson, DO · Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2023-10-30
Completion
2023-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181188 on ClinicalTrials.gov