Skip to main content
OpenTrials
Completed

NCT Number: NCT03387644

Pregabalin Premedication for Conscious Sedation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Conscious Sedation

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two equal groups, 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients sedated to achieve optimum working conditions. Intra-operative respiratory rate and post procedure patients' and pulmonologists' satisfaction were compared in both groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Pregabalin (PG)

Drug

Pregabalin 150 mg one hour before the procedure as premedication.

Other names: Pregabalin for premedication

Control placebo (C)

Drug

Placebo tablets one hour before the procedure as premedication.

Other names: Placebo for premeditation

Primary outcomes

  1. Total amount of sedative

    Time frame: 45 minutes during the procedure

    The total amount of the sedative used during the procedure.

Secondary outcomes

  1. Patients' satisfaction

    Time frame: 30 minutes after the end of the procedure.

    Patient's satisfaction score was recorded using a score ranging from 0 not satisfied and 5 totally satisfied. The score was done using a questioner designed by the researchers.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Pregabalin Premedication for Conscious Sedation for Flexible Bronchoscopy: A Randomized Double Blind Controlled Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 2, 2018
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.