Clinical Research Directory

Effects of Sedation Agents on Optic Nerve Sheath Diameter

This prospective observational study aims to evaluate the acute effects of ketamine and propofol sedation on optic nerve sheath diameter (ONSD) in adult patients undergoing procedural sedation in the emergency department. ONSD is a noninvasive ultrasonographic measurement that may reflect changes in intracranial pressure. Adult patients who receive intravenous ketamine or propofol for procedural sedation will be included. The sedative agent will be selected by the treating physician according to routine clinical practice, and patients will not be randomly assigned to treatment groups. ONSD will be measured using ocular ultrasonography before and after sedation. The primary purpose of the study is to compare changes in ONSD following ketamine and propofol administration and to evaluate whether these commonly used sedative agents have different effects on ONSD.

Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department.

This randomized controlled trial will compare two medication combinations, ketamine-dexmedetomidine (Ketadex) and ketamine-propofol (Ketofol), for procedural sedation in adults undergoing painful procedures in the emergency department. The primary objective is to compare the respiratory safety of the two sedation regimens, particularly the occurrence of hypoxic events and the need for airway interventions. Participants will be randomly assigned to receive either Ketadex or Ketofol. The study will also compare recovery time, hemodynamic effects, pain, emergence reactions, nausea and vomiting, and other adverse events between the two groups. The study will be conducted in the Emergency Department at Sultan Qaboos University Hospital, University Medical City, Oman.

Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2

The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel. The main question it aims to answer is: • Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke? GA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased. Researchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke. Participants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.

Personalized Music, Dreaming During Propofol Sedation

This randomized clinical trial will evaluate whether music delivered through closed-back headphones during intravenous propofol sedation affects dreaming and the overall sedation experience. Adults scheduled for elective procedures under spinal anesthesia or peripheral nerve block with propofol sedation will be randomly assigned to one of three groups: patient-selected preferred music, matched non-preferred music, or silence with identical headphones. The main purpose of the study is to determine whether listening to music increases the occurrence of dream recall compared with silence, and whether personally preferred music makes recalled dreams more pleasant than matched non-preferred music. Dream recall and dream pleasantness will be assessed after recovery using a standardized interview. The study will also evaluate dream content, patient satisfaction, sedative and opioid requirements, hemodynamic variability, postoperative pain, nausea and vomiting, recovery time, and adverse events. This study is intended to determine whether a simple, low-cost headphone-based music intervention can improve patient-centered quality of propofol sedation without compromising safety.

Therapeutic Effects of Music on Procedural Outcomes

This study will evaluate whether listening to low-tempo instrumental music during gastroscopy and/or colonoscopy can reduce the amount of sedative medication needed during the procedure. Adults undergoing elective gastroscopy and/or colonoscopy with sedation will be randomly assigned to one of two groups. One group will listen to low-tempo instrumental music (60-80 beats per minute) through headphones during the procedure in addition to receiving standard sedation. The other group will receive standard sedation without music. The main outcome of the study is the amount of sedative medication required during the procedure. The study will also compare pain after the procedure, time until discharge, patient satisfaction, and changes in heart rate and blood pressure between the two groups. The researchers hypothesize that patients who listen to low-tempo music will require less sedative medication and may have improved recovery and patient-reported outcomes compared with patients receiving standard sedation alone.

SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation

The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult patients at Hospital Clínic de Barcelona, Spain. Procedural sedation consists in the administration of sedative and analgesic drugs to allow patients to undergo routine diagnostic or therapeutic procedures comfortably. Despite advances in monitoring technology, adverse events such as arterial hypotension, respiratory depression, or inadequate sedation remain frequent due to marked interindividual variability in drug response. Currently, clinicians rely on standard physiological monitoring that measures what is happening in real time but does not anticipate what is about to happen. SED Pack is designed to address this gap by continuously processing physiological monitoring data and drug-infusion information to generate four real-time predictive indices (updated once per second): pSED (sedation depth), pNOC (likelihood of response to a noxious stimulus), pHYPO (likelihood of arterial hypotension), and pDEP (likelihood of respiratory depression). In this clinical investigation, one hundred and twenty adult patients (≥18 years, ASA I-III) will be enrolled. Predictive performance is evaluated using the c-index for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC. The primary hypothesis is that each index achieves a discrimination performance ≥0.70 (lower bound of the 95% CI also ≥0.70). The software runs in fully blinded mode: its predictions are not visible to clinicians and do not influence patient management. No additional procedures beyond standard clinical care are introduced. The study complies with MDR 2017/745 and ISO 14155, with AEMPS authorization and CEIm approval (reference: HCB/2026/0307). Expected outcomes include confirmation that each SED Pack predictive index achieves clinically acceptable discrimination performance, supporting the clinical use of this investigational software as a tool to anticipate and prevent sedation-related complications.

Ketodex Versus Ketofol in Adolescent Gastrointestinal Endoscopy

Gastrointestinal endoscopic procedures in adolescents require effective sedoanalgesia to ensure procedural comfort and prevent agitation. Pain control is an essential component of these procedures, and current practice commonly involves low-dose combinations of anesthetic agents. Sedoanalgesia protocols are selected according to patient characteristics and the anesthesiologist's clinical experience. This prospective observational study aims to compare the effects of ketodex and ketofol on intraoperative procedural comfort, postoperative recovery, and patient satisfaction in adolescents undergoing gastrointestinal endoscopy.

Ciprofol Versus Propofol With Low-Dose Sufentanil for Painless Bronchoscopy

Bronchoscopy may cause coughing, discomfort, body movement, and changes in breathing or blood pressure. Propofol is commonly used for sedation during bronchoscopy, but it may cause respiratory depression, circulatory depression, and injection pain. Ciprofol is another intravenous sedative that may provide effective sedation with fewer adverse effects. This study compared ciprofol combined with low-dose sufentanil with propofol combined with low-dose sufentanil in adults undergoing bronchoscopy under intravenous sedation. A total of 100 adults aged 35 to 65 years with no or mild systemic disease were randomly assigned in a 1:1 ratio to two treatment groups. Participants in one group received ciprofol and low-dose sufentanil, while participants in the other group received propofol and low-dose sufentanil. The study evaluated the amount of sedative used, adverse events, sedation onset time, recovery time, recovery quality, blood pressure, heart rate, oxygen saturation, and the overall effectiveness of anesthesia.

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.

Remimazolam-Propofol Combination Sedation for Gastrointestinal Endoscopy: A Prospective Observational Study

This prospective observational study evaluated the safety and efficacy of a remimazolam-propofol combination sedation protocol in adult patients undergoing elective gastrointestinal endoscopy at a tertiary care centre in Romania. The primary outcome was procedural completion. Secondary outcomes included time to sedation onset, recovery time, discharge readiness, total sedative doses administered, and incidence of adverse events including cardiovascular and respiratory complications.

Propofol vs Remifentanil for Sedation in Gastroscopy

This prospective randomized study aims to compare propofol and remifentanil for sedation during elective diagnostic gastroscopy. The ideal sedative agent for gastroscopy should provide adequate sedation, rapid recovery, patient safety, and high endoscopist satisfaction. Although propofol is widely used for procedural sedation, remifentanil's ultra-short pharmacokinetic profile may offer advantages in short procedures such as gastroscopy. However, comprehensive comparative data evaluating recovery quality, safety, and procedural conditions between these agents remain limited. This study evaluates sedation efficacy, recovery characteristics, complication rates, and endoscopist satisfaction associated with propofol- and remifentanil-based sedation protocols.

Remimazolam vs Propofol in Laser Burn Cases

This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative CO₂ laser therapy for burn scars. The primary aim is to assess incidence of respiratory depression, defined as a need for advanced airway maneuvers (jaw thrust/chin lift, insertion of oral or nasal airway, or bag mask ventilation), and hypopnea (respiratory rate \< 8).

Effect of Discontinuing Propofol After Cecal Intubation on Patient's Psychomotor Recovery Following Colonoscopy

This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.

The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study

Propofol is currently the most common drug used but has drawbacks like narrow therapeutic window and potential complications. Dexmedetomidine is an attractive alternative due to its unique properties like minimal respiratory depression. Studies are ongoing to find the optimal use of dexmedetomidine for these procedures. A combination of propofol and dexmedetomidine might be ideal, but the best balance between the two drugs needs further investigation.