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Pregabalin Premedication for Conscious Sedation

M

Menoufia University

Status

Completed

Conditions

Conscious Sedation

Treatments

Drug: Control placebo (C)
Drug: Pregabalin (PG)

Study type

Interventional

Funder types

Other

Identifiers

NCT03387644
MenoufiaU2015/5

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups, including a placebo group

Pregabalin (PG)
Active Comparator group
Description:
Patients received 150 mg pregabalin one hour before the procedure.
Treatment:
Drug: Pregabalin (PG)
Control placebo (C)
Placebo Comparator group
Description:
Patients received placebo tablet one hour before surgery.
Treatment:
Drug: Control placebo (C)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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