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Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial

NCT ID: NCT04211298

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-08-01

Brief Summary

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The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.

The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications

Detailed Description

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Conditions

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Sedation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine

Dexmedetomidine will be used for sedation during bronchoscopy

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine will be used for sedation during bronchoscopy

Propofol

Propofol will be used for sedation during bronchoscopy

Group Type PLACEBO_COMPARATOR

Propofol

Intervention Type DRUG

Propofol

Interventions

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Dexmedetomidine

Dexmedetomidine will be used for sedation during bronchoscopy

Intervention Type DRUG

Propofol

Propofol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center

Exclusion Criteria

* known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine \> 2 mg/dL) or hepatic impairment (elevated liver enzymes \> 2 times normal), haemodynamic instability (bradycardia with HR \< 50 bpm or hypotension with SBP \< 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mordechai Kremer

Head of the pulmonary division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Barak Pertzov, MD

Role: CONTACT

Phone: 972548080196

Email: [email protected]

Mordechai Kramer, MD

Role: CONTACT

Phone: 97239377224

Email: [email protected]

Facility Contacts

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Mordechai R Kramer, MD

Role: primary

References

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Pertzov B, Krasulya B, Azem K, Shostak Y, Izhakian S, Rosengarten D, Kharchenko S, Kramer MR. Dexmedetomidine versus propofol sedation in flexible bronchoscopy: a randomized controlled trial. BMC Pulm Med. 2022 Mar 15;22(1):87. doi: 10.1186/s12890-022-01880-9.

Reference Type DERIVED
PMID: 35291989 (View on PubMed)

Other Identifiers

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0312-19-RMC

Identifier Type: -

Identifier Source: org_study_id