Pregabalin Premedication for Conscious Sedation

Conscious Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387644
• Other study ID #: MenoufiaU2015/5
• Status: Completed
• Phase: N/A
• First received: December 15, 2017
• Last updated: December 22, 2017
• Start date: April 15, 2015
• Est. completion date: May 16, 2017

Study information

• Verified date: December 2017
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 16, 2017
• Est. primary completion date: November 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Pregabalin (PG)
Pregabalin 150 mg one hour before the procedure as premedication.
• Control placebo (C)
Placebo tablets one hour before the procedure as premedication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of sedative	The total amount of the sedative used during the procedure.	45 minutes during the procedure
Secondary	Patients' satisfaction	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.	30 minutes after the end of the procedure.