Pregabalin Premedication for Knee Arthroscopy

Knee Arthroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03926000
• Other study ID #: MenoufiaU2019/7
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2019
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroscopy

Intervention

Drug:
• Pregabalin (PG)
Pregabalin 150 mg one hour before the procedure as premedication.
• Control placebo (C)
Placebo tablets one hour before the procedure as premedication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of anesthetics	Total amount of anesthetics used during the procedure.	45 minutes during the procedure
Secondary	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