Clinical Research Directory

Light and Anesthesia

The objective of this clinical trial is to investigate the effect of light exposure on sedation depth during general anesthesia.The primary research questions this study aims to address include: Does light condition affect the dosage of anesthetic medications during anesthesia? By what mechanism does light exposure exert an influence on anesthesia? Participants will be randomly allocated to either the light-shielded group or the non-light-shielded group.Patients in the light-shielded group will wear an eye shield during anesthesia. The following data will be recorded for all patients: Induction drug dosage Induction time Intraoperative anesthetic dosage Emergence time

Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial

Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.

Intra-Operative Adductor Canal Blocks

Adductor canal blocks (ACB) have been recommended in total knee arthroplasty (TKA) to provide better control of post-operative pain, facilitate early ambulation, and reduce length of stay in the hospital. ACB is typically done before surgery by an anesthesiologist, which may increase time per case, cost, and requires the specialized skills of an anesthesiologist trained in regional anesthesia. Recent studies have suggested that surgeons can safely and reliably administer the adductor canal blocks (sACB) during surgery. However, there is currently very limited data on the clinical efficacy of such sACBs, and no studies assessing this technique in the context TKA that are discharged the same day. As such, this randomized control trial (RCT) is being done to compare sACBs to conventional anesthesiologist-performed adductor canal blocks (aACB).

Effect of Total Intravenous Anesthesia vs Inhalational Anesthesia on the Level of Inflammatory Markers

This study aims to compare the effects of total intravenous anesthesia (TIVA) vs inhalational anesthesia on postoperative levels of inflammatory markers, length of hospital stay, and the incidence of postoperative nausea and vomiting in patients undergoing inguinal hernia repair. Number participants: Participants will be divided into 2 groups with sample size of at least 20 patients per group. Plan of the work: All patients will receive general anesthesia according to Ain Shams hospital protocol which follows the standards of the American Society of Anesthesiologists. Group A will be TIVA group and Group B will be Sevoflurane group. Sample Collection and Laboratory Analysis: Venous blood samples will be collected from each patient at three time points: preoperative (baseline, sample 0), 6 hours postoperative (sample 1), and 24 hours postoperative (sample 2).

The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery

Low blood pressure, also known as hypotension, is very common during major surgery under general anesthesia. Prolonged or severe hypotension can lead to complications such as kidney injury after surgery that slow down patient recovery. Anesthesiologists commonly administer medications called vasopressors to treat low blood pressure during surgery. These medications help raise the blood pressure back up to a safe range. Two vasopressor medications are commonly used for this purpose: norepinephrine and phenylephrine. Each of these medications has slightly different effects on the heart and blood vessels (cardiovascular system). It remains unknown which of these standard medications is better for treating low blood pressure during surgery. The goal of this clinical trial is to determine which of these two medications is better at preventing injury to the kidneys after major noncardiac surgery as well as other complications such as heart problems. Major surgeries are defined as those lasting at least two hours under general anesthesia. This trial will randomize about ten centers in North America to use either norepinephrine or phenylephrine as the primary medication to treat low blood pressure in adults undergoing major noncardiac surgery. Each hospital will prioritize one of the drugs each month, and the assigned drug will rotate each month at each hospital. No further participant involvement will be required as de-identified data are collected as part of standard medical care.

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

This study is a pragmatic, randomized controlled pilot trial comparing remimazolam with propofol for endoscopic procedures, designed to assess the feasibility and clinical outcomes associated with implementing a pragmatic randomized trial of sedation practices in the endoscopy setting.

End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children

Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children. During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are. The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment.

Ketamine and Propofol NeuroImaging

This is a multi-visit which will collect MRI (pictures of the brain) and EEG (brain waves) data to determine changes in brain connectivity and brain activity for memory formation and pain perception while receiving the commonly-used anesthetic agents ketamine and propofol, both alone and in combination.

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.

Comparison of the Effect of Preoperative and Postoperative ESP and PVB on Postoperative Pain in VATS

The aim of this prospective controlled randomised clinical trial was to identify the analgesic method that is more effective than two different regional analgesia techniques routinely used for pain control after video-assisted thoracic surgery (VATS). The effects of paravertebral block and erector spina plan (ESP) block on acute pain, need for additional analgesics and incidence of chronic pain after video-assisted thoracic surgery (VATS) will be compared before surgical incision (pre-emptive) and at the end of surgery. The aim is to demonstrate that the ESP block, a relatively newer method in the literature, provides analgesia comparable to that of the paravertebral block.

Lumbar ESPB in Hip Replacement Surgery

In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed.

Cognitive Assessment And Post-Operative Complications After Surgery: Linking Anaesthesia And Risk

Many older people can experience confusion, memory problems, or a decline in their thinking after major surgery. These problems are sometimes called 'postoperative neurocognitive disorders' or PND and can affect recovery and a person's ability to live independently. The investigators want to find out the best way to study these problems in older patients undergoing surgery. This is a 'feasibility study', which means we are testing the research methods. The investigators want to see if it is possible to ask participants to do memory tests and give blood samples before and after their operation. The investigators are hoping to include around 40 patients over 2 years in this study. The investigators will compare performance in memory (cognitive assessment) findings before and after surgery and link this to data taken from the anaesthetic, including the types of drugs used, duration, brain features from processed electroencephalogram monitoring and standard recommended monitoring. In addition the investigators will link this to blood sample markers of brain health and function (biomarkers). The results of this study will help the investigators plan a much larger study in the future, with the ultimate goal of making surgery safer for the brain.

Effectiveness of Large Language Model for Anaesthesia and Procedural Consent

Patient understanding of anaesthesia risks remains inconsistent due to time constraints, language barriers, and variable clinician communication styles. Traditional verbal consent may not consistently ensure comprehension or reduce preoperative anxiety. PEAR (Patient Education of Anesthesia Risks) is a multilingual, AI-driven chatbot developed to enhance patient education and improve the quality of anaesthesia risk counselling. Study Objective: To compare PEAR's performance in delivering anaesthesia risk consent against the standard face-to-face verbal method.

Metabolic Control in Anesthesia and Surgery

The goal of this observational study is to investigate how a standard dose of the drug dexamethasone affects blood sugar levels during and after non-cardiac surgery in adult patients. The main questions it aims to answer are: * How does dexamethasone influence blood sugar levels in patients undergoing non-cardiac surgery? * Does continuous glucose monitoring (CGM) provide a more accurate estimate of blood sugar fluctuations compared to traditional time-specific finger-prick measurements? Participants are scheduled to receive dexamethasone as part of standard anesthesia care and will undergo their planned surgery. As part of the study, a continuous glucose monitoring (CGM) device will be placed on their upper arm approximately 12 hours before surgery and will remain in place for up to 10 days after the operation. During this period, their blood sugar levels will be measured using both the CGM device and traditional finger-prick tests. CGM readings are blinded for both participants and clinicians. No additional treatments or changes to their standard care will be made as a result of their participation in the study. The study will include 100 adult patients from the Department of Anesthesiology at Sjællands University Hospital, Roskilde.

Total Intravenous Anesthesia in Patients Undergoing Craniotomy

Craniotomy presents true anesthetic challenges, mainly due to the need to optimize cerebral perfusion, facilitate brain relaxation, achieve rapid emergence for neurologic assessment, and minimize perioperative complications.

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

This randomized controlled trial evaluates whether intraoperative guidance using the CoreSys monitor reduces the surgical stress response in patients undergoing elective open abdominal hysterectomy. Surgical stress involves complex hemodynamic, endocrine, and inflammatory responses that may negatively impact postoperative recovery. Patients will be randomized to either anesthesia guided by conventional clinical and hemodynamic parameters or anesthesia additionally guided by CoreSys-derived indices of consciousness, nociception, and stress activity. The primary objective is to assess whether CoreSys-guided anesthesia attenuates stress biomarkers, including interleukin-6 (IL-6), cortisol and glycemia.

Opioid-free Anaesthesia in Breast Cancer Surgery

Background: Various analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. Opioid-free and opioid-sparing techniques are gaining popularity due to the lack of opioid-dependent undesirable effects, including respiratory depression, urinary retention, nausea and vomiting, constipation, itching, opioid-induced hyperalgesia, tolerance, addiction, and immune system disorders. The goal of this prospective randomized clinical trial is to investigate the impact of opioid-free anaesthesia (OFA) versus conventional general anaesthesia (CGA) on postoperative analgesic requirements after breast cancer surgery (lumpectomy/mastectomy, with or without axillary lymph node excision). Secondary objectives include comparative perioperative evaluation of cognitive function and postoperative adverse events during the first 48 hours atfter surgery. Comparative evaluation of intraoperative haemodynamics and hospital length of stay are also secondary objectives, as well as the incidence of neuropathic pain assessed by validated questionnaires at 3 and 6 months postoperatively. During the preoperative screening, body measurements, age, gender, ASA (American Society of Anesthesiologists) physical status classification, educational level (using a 6-level scale: elementary, middle school, high school, higher education, higher education, and postgraduate/doctoral degree), home medication, and comorbidities (using the Charlson Comorbidity Index) are recorded. Intraoperatively, the duration of anaesthesia, duration of surgery, associated intraoperative data (e.g., haemodynamic instability, adverse effects associated with protocol-administered pharmaceutical agents, etc.), and medications administered (type and quantity) are recorded. The investigators expect to recruit at least 100 participants per group.

The Risk of Surgical Cancellation in Adult Patients Assessed by Telephone Versus In-person for Scheduled Non-cardiac Elective Surgery.

Telemedicine has been regulated in Colombia since 2006, with applications in anesthesia being explored since 2004 to improve accessibility and reduce costs. Although Decree 538 of 2020 expanded telemedicine's medical applications, challenges such as connectivity issues and training needs remain. Telemedicine has shown promise in rural areas of Colombia, particularly for managing chronic diseases. However, further evidence is needed regarding the effectiveness of telephone pre-anesthetic evaluations. This study aims to investigate the implementation of telephone assessments for non-cardiac surgery and their impact on surgical cancellations compared to in-person pre-anesthetic evaluations. The primary question to answer is: ¿Does telephone pre-anesthetic assessment in non-cardiac surgical patients carry a higher risk of surgical cancellations compared to in-person evaluations? To address this question, investigators will evaluate patients' medical records in two hospitals where patients were assessed using both telephone and in-person modalities.

International Focus Group Discussion on Neuromuscular Monitoring.

Focus-Group based discussion designed to gain more in-depth information on factors that could lead to an increase in the adoption of neuromuscular monitoring taking into account different country-specific contexts.

Anesthetics and Analgesics in Children

The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.

Pre-anesthetic Teleconsultations During Pregnancy

Quality of teleconsultation in comparison to face-to-face consultation for pre anesthetic evaluation in pregnant persons before delivery will be evaluated. Quality is evaluated with a composite criterion comprising 7 elements required for security of anesthesia. Discordance between this composite criterion during the pre anesthesia visit the day of delivery and pre anesthesia consultation several weeks before delivery will be assessed.

VR Based Simulation in the Preparation of Children for MRI - MRVR

The goal of this randomized controlled trial is to evaluate whether a virtual reality based preparation method can efficiently decrease the proportion of children requiring general anesthesia during MRI examinations. Participants will take part in a virtual reality environment resembling an MRI before their scheduled MRI examination. Researchers will compare these children to usual care and a booklet based preparation method to see if less children need anesthesia for completing the MRI examination.

Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service

A comparison of two anesthetic techniques for total knee replacements: (1) Peri-Articular Injection (PAI), local infiltration between the popliteal artery and capsule of the knee block (IPACK) and single-shot adductor canal block (ACB) vs. (2) PAI, IPACK and continuous adductor canal block catheter (ACC).

Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System

The pharmacokinetic profile of various drugs is altered in obese patients especially those administered by the intravenous route. Propofol is the commonly used intravenous anesthetic agent for induction and maintenance of anaesthesia as part of total intravenous anaesthesia (TIVA) regimen. A major concern with propofol dosing based on total body weight (TBW) in obese patients is disproportionate drug administration leading to undue drug accumulation in body with a potential to overdosing, delayed recovery from anaesthesia, and adverse hemodynamic outcome. Studies on propofol dosing based on various weight scalars have recommended that lean body weight (LBW) should be used for calculating bolus dose during anaesthesia induction and TBW or adjusted body weight (ABW) for arriving at an infusion dose required for maintenance of anesthesia. Although propofol delivery based on dose calculated by TBW has been well researched the evidence for propofol delivery based on dose calculated by ABW is lacking. Recent advance in the delivery of propofol has been the development of computer controlled anaesthesia delivery systems. These devices deliver propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration. One such indigenously developed computer controlled anaesthesia delivery system is the closed loop anesthesia delivery system (CLADS). CLADS functions on control of processed EEG response parameter captured from anesthetized patients with the help of a BIS- monitor, which is continuously fed into an automated drug infusion pump. The infusion pump then accordingly delivers the anesthetic drug to the patients based on pharmacodynamic requirements. The investigators plan to evaluate the propofol maintenance dose requirement based on TBW versus ABW using CLADS for propofol delivery.