Drug Safety

2

Review clinical trials related to Drug Safety. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial

This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.

Participants needed: 373
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Hui XuUpdated: Apr 16, 2025Locations: 1
Eligibility criteria

Adult age (18-65 years old) [+4]

Those who have contraindications to general anesthesia or have a history of anes... [+10]

Status: Not yet recruiting

Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.

The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening. The main question it aims to answer is: • Does use of intranasal midazolam is a safe, quick, non-invasive medication, that reduces the pain, stress, discomfort, and other complications in patients undergoing ROP screening? Researchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.

Participants needed: 40
Trial details
Phase: Phase 1Age: Up to 30Biological sex: AllType: InterventionalSponsor: Polish Mother Memorial Hospital Research InstituteUpdated: Mar 21, 2025Locations: 1
Eligibility criteria

Obtaining informed consent from a parent/legal guardian.

Newborns/infants not qualified for screening ophthalmologic examination (ROP). [+3]