Pregabalin Premedication for Knee Arthroscopy

NCT ID: NCT03926000

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Arthroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregabalin (PG)

Patients will receive 150 mg pregabalin one hour before the procedure.

Group Type ACTIVE_COMPARATOR

Pregabalin (PG)

Intervention Type DRUG

Pregabalin 150 mg one hour before the procedure as premedication.

Control placebo (C)

Patients will receive placebo tablet one hour before surgery.

Group Type PLACEBO_COMPARATOR

Control placebo (C)

Intervention Type DRUG

Placebo tablets one hour before the procedure as premedication.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pregabalin (PG)

Pregabalin 150 mg one hour before the procedure as premedication.

Intervention Type DRUG

Control placebo (C)

Placebo tablets one hour before the procedure as premedication.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pregabalin for premedication Placebo for premeditation.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Menoufia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Ezzeldin Ibrahim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MenoufiaU2019/7

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pregabalin for Central Sensitization in TKA
NCT05460871 TERMINATED PHASE4
Pregabalin and Post-thoracotomy Pain
NCT00663962 COMPLETED PHASE4