Pregabalin Premedication for Conscious Sedation

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

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.

Study Overview

• Status: Completed
• Conditions: Conscious Sedation
• Intervention / Treatment: Drug: Pregabalin (PG); Drug: Control placebo (C)

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pregabalin (PG); Patients received 150 mg pregabalin one hour before the procedure.	Drug: Pregabalin (PG); Pregabalin 150 mg one hour before the procedure as premedication.; Other Names: Pregabalin for premedication
Placebo Comparator: Control placebo (C); Patients received placebo tablet one hour before surgery.	Drug: Control placebo (C); Placebo tablets one hour before the procedure as premedication.; Other Names: Placebo for premeditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of sedative	The total amount of the sedative used during the procedure.	45 minutes during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2015
• Primary Completion (Actual): November 24, 2016
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: MenoufiaU2015/5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No