NCT03387644

Brief Summary

Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and midazolam.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

1.6 years

First QC Date

December 15, 2017

Last Update Submit

December 22, 2017

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

  • Total amount of sedative

    The total amount of the sedative used during the procedure.

    45 minutes during the procedure

Secondary Outcomes (1)

  • Patients' satisfaction

    30 minutes after the end of the procedure.

Study Arms (2)

Pregabalin (PG)

ACTIVE COMPARATOR

Patients received 150 mg pregabalin one hour before the procedure.

Drug: Pregabalin (PG)

Control placebo (C)

PLACEBO COMPARATOR

Patients received placebo tablet one hour before surgery.

Drug: Control placebo (C)

Interventions

Pregabalin (PG)DRUG

Pregabalin 150 mg one hour before the procedure as premedication.

Also known as: Pregabalin for premedication
Pregabalin (PG)
Control placebo (C)DRUG

Placebo tablets one hour before the procedure as premedication.

Also known as: Placebo for premeditation
Control placebo (C)

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 21 and 65 years old American Society of Anaesthesiologists physical status II or III scheduled for elective flexible bronchoscopy

You may not qualify if:

  • Patients with known allergy to any drug used in the study, chronic use of analgesics and/or sedatives, substance abuse, sleep apnea, renal or hepatic dysfunction, and psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PregabalinPremedication

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in anaesthesia, intensive care, and pain medicine.

Study Record Dates

First Submitted

December 15, 2017

First Posted

January 2, 2018

Study Start

April 15, 2015

Primary Completion

November 24, 2016

Study Completion

May 16, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12