Pregabalin Premedication for Conscious Sedation

Not Applicable

Completed

• Conditions: Conscious Sedation
• Interventions: Drug: Control placebo (C); Drug: Pregabalin (PG)

• Registration Number: NCT03387644
• Lead Sponsor: Menoufia University

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.

Detailed 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.

Study Timeline

• Study Start: 2015-04-15
• Primary Completion: 2016-11-24
• Study Completion: 2017-05-16
• Status Verified: 2017-12
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-22
• Last Update Submitted: 2017-12-22
• Study First Posted: 2018-01-02
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control placebo (C)	Control placebo (C)	Patients received placebo tablet one hour before surgery.
Pregabalin (PG)	Pregabalin (PG)	Patients received 150 mg pregabalin one hour before the procedure.

Primary Outcome Measures

Name	Time	Method
Total amount of sedative	45 minutes during the procedure	The total amount of the sedative used during the procedure.

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction	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.