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出境医 / 临床实验 / Pregabalin Premedication for Knee Arthroscopy

Pregabalin Premedication for Knee Arthroscopy

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
Layout table for study information
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
Layout table for eligibility information
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

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date April 25, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		Total amount of anesthetics [ Time Frame: 45 minutes during the procedure ]
Total amount of anesthetics used during the procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregabalin Premedication for Knee Arthroscopy
Official Title  ICMJE The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Knee Arthroscopy
Intervention  ICMJE
  • Drug: Pregabalin (PG)
    Pregabalin 150 mg one hour before the procedure as premedication.
    Other Name: Pregabalin for premedication
  • Drug: Control placebo (C)
    Placebo tablets one hour before the procedure as premedication.
    Other Name: Placebo for premeditation.
Study Arms  ICMJE
  • Active Comparator: Pregabalin (PG)
    Patients will receive 150 mg pregabalin one hour before the procedure.
    Intervention: Drug: Pregabalin (PG)
  • Placebo Comparator: Control placebo (C)
    Patients will receive placebo tablet one hour before surgery.
    Intervention: Drug: Control placebo (C)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926000
Other Study ID Numbers  ICMJE MenoufiaU2019/7
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Ezzeldin Ibrahim, Menoufia University
Study Sponsor  ICMJE Menoufia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Menoufia University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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