Pregabalin Premedication for Knee Arthroscopy

Not Applicable

• Conditions: Knee Arthroscopy
• Interventions: Drug: Pregabalin (PG); Drug: Control placebo (C)

• Registration Number: NCT03926000
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Study First Posted: 2019-04-24
• Last Update Posted: 2019-04-25
• Study Start: 2019-06
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total amount of anesthetics	45 minutes during the procedure	Total amount of anesthetics used during the procedure.

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction: satisfaction score	30 minutes after the end of the procedure	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.