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Pregabalin Premedication for Conscious Sedation

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. Read our disclaimer for details. Identifier: NCT03387644
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Information provided by (Responsible Party):
Dr Ezzeldin Ibrahim, Menoufia University

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
Conscious Sedation Drug: Pregabalin (PG) Drug: Control placebo (C) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 15, 2015
Actual Primary Completion Date : November 24, 2016
Actual Study Completion Date : May 16, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

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 Name: 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 Name: Placebo for premeditation

Primary Outcome Measures :
  1. Total amount of sedative [ Time Frame: 45 minutes during the procedure ]
    The total amount of the sedative used during the procedure.

Secondary Outcome Measures :
  1. Patients' satisfaction [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
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.

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Responsible Party: Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University Identifier: NCT03387644     History of Changes
Other Study ID Numbers: MenoufiaU2015/5
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017

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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