Pregabalin Premedication for Knee Arthroscopy

Study Overview
=================
Brief Summary
-----------------
Outpatient arthroscopic knee surgery can be performed with general or regional anesthesia. Recent data suggest that spinal and epidural anesthesia require longer discharge times than the newer shorter-acting general anesthetic drugs. Ideal premedication drug should relieve anxiety, produce amnesia and sedation, decrease secretions, prevent nausea and vomiting, have dose sparing effect on the anaesthetic drugs, and suppress pressor response to laryngoscopy and intubation. Recently, gabapentin and pregabalin were suggested as pre-operative drugs to decrease anxiety, stress response to laryngoscopy and post operative pain.

Detailed Description
-----------------
112 patients undergoing elective knee arthroscopy will randomly divided into two equal groups, 56 patients each. All patients will receive premedication one hour before the procedure. PG group will receive 150 mg pregabalin and C group will receive placebo. All patients will receive total intravenous anesthesia to achieve optimum working conditions. Intra-operative total amount of anesthetics will be compared in both groups.

Official Title
-----------------
The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy

Conditions
-----------------
Knee Arthroscopy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective knee arthroscopy. Patients aged between 21 and 50 years old. Patients with American Society of Anaesthesiologists physical status I or II. Exclusion Criteria: Patients with known allergy to any drug used in the study. Patients with chronic use of analgesics and/or sedatives. Patients with sleep apnea syndrome. Patients with renal or hepatic dysfunction. Patients with psychiatric disorders.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 will receive 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 will receive 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 anesthetics | Total amount of anesthetics used during the procedure. | 45 minutes during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction: satisfaction score | Patient's satisfaction score will be recorded using a score ranging from 0 not satisfied and 5 totally satisfied. The score will be done using a questioner designed by the researchers. | 30 minutes after the end of the procedure |