Pregabalin Premedication for Knee Arthroscopy

• ClinicalTrials.gov Identifier: NCT03926000
• Recruitment Status: Unknown
• First Posted: April 24, 2019
• Last Update Posted: April 25, 2019
• Sponsor: Menoufia University
• Information provided by (Responsible Party): Dr Ezzeldin Ibrahim, Menoufia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Knee Arthroscopy	Drug: Pregabalin (PG); Drug: Control placebo (C)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy
• Estimated Study Start Date: June 2019
• Estimated Primary Completion Date: November 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

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 Name: 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 Name: Placebo for premeditation.

Outcome Measures

Primary Outcome Measures :

1. Total amount of anesthetics [ Time Frame: 45 minutes during the procedure ]
   Total amount of anesthetics used during the procedure.

Secondary Outcome Measures :

1. Patients' satisfaction: satisfaction score [ Time Frame: 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.

Eligibility Criteria

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

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Dr Ezzeldin Ibrahim, Professor, Menoufia University
• ClinicalTrials.gov Identifier: NCT03926000
• Other Study ID Numbers: MenoufiaU2019/7
• First Posted: April 24, 2019
• Last Update Posted: April 25, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pregabalin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs