Pregabalin Premedication for Conscious Sedation

Study Overview
=================
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.

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

Conditions
-----------------
Conscious Sedation

Intervention / Treatment
-----------------
* Drug: Pregabalin (PG)
* Drug: Control placebo (C)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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