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Trial record 9 of 424 for:    Pregabalin

Pregabalin Premedication for Knee Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03926000
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Information provided by (Responsible Party):
Dr Ezzeldin Ibrahim, 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.

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

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.

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.

Information from the National Library of Medicine

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

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.

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Responsible Party: Dr Ezzeldin Ibrahim, Professor, Menoufia University Identifier: NCT03926000     History of Changes
Other Study ID Numbers: MenoufiaU2019/7
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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

Additional relevant MeSH terms:
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Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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