Pregabalin Premedication for Conscious Sedation
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|ClinicalTrials.gov 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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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 :
- Total amount of sedative [ Time Frame: 45 minutes during the procedure ]The total amount of the sedative used during the procedure.
Secondary Outcome Measures :
- 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.
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