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Pregabalin Premedication for Conscious Sedation

Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT03387644
Collaborator
(none)
70
Enrollment
2
Arms
25
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and midazolam.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregabalin (PG)
  • Drug: Control placebo (C)
 N/A

Detailed Description

Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two equal groups, 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients sedated to achieve optimum working conditions. Intra-operative respiratory rate and post procedure patients' and pulmonologists' satisfaction were compared in both groups.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Pregabalin Premedication for Conscious Sedation for Flexible Bronchoscopy: A Randomized Double Blind Controlled Study
Actual Study Start Date :
Apr 15, 2015
Actual Primary Completion Date :
Nov 24, 2016
Actual Study Completion Date :
May 16, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pregabalin (PG)

Patients received 150 mg pregabalin one hour before the procedure.

Drug: Pregabalin (PG)
Pregabalin 150 mg one hour before the procedure as premedication.
Other Names:
  • Pregabalin for premedication

    		•
    Placebo Comparator: Control placebo (C)

    Patients received placebo tablet one hour before surgery.

    Drug: Control placebo (C)
    Placebo tablets one hour before the procedure as premedication.
    Other Names:
  • Placebo for premeditation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total amount of sedative [45 minutes during the procedure]

      The total amount of the sedative used during the procedure.

    Secondary Outcome Measures

    1. Patients' satisfaction [30 minutes after the end of the procedure.]

      Patient's satisfaction score was recorded using a score ranging from 0 not satisfied and 5 totally satisfied. The score was done using a questioner designed by the researchers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged between 21 and 65 years old American Society of Anaesthesiologists physical status II or III scheduled for elective flexible bronchoscopy
    Exclusion Criteria:
    • Patients with known allergy to any drug used in the study, chronic use of analgesics and/or sedatives, substance abuse, sleep apnea, renal or hepatic dysfunction, and psychiatric disorders.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Menoufia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University
    ClinicalTrials.gov Identifier:
    NCT03387644
    Other Study ID Numbers:
    • MenoufiaU2015/5
    First Posted:
    Jan 2, 2018
    Last Update Posted:
    Jan 2, 2018
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pregabalin

    Study Results

    No Results Posted as of Jan 2, 2018