Pregabalin Premedication for Knee Arthroscopy

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Arthroscopy
• Intervention / Treatment: Drug: Pregabalin (PG); Drug: Control placebo (C)

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 Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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 will receive 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 will receive 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 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

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

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: MenoufiaU2019/7

Drug and device information, study documents

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