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13 clinical studies listed.

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Orthopedic Surgery

Tundra lists 13 Orthopedic Surgery clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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NOT YET RECRUITING

NCT07468162

Characteristic Electroencephalogram of General Anesthesia

Patients were enrolled according to predefined inclusion and exclusion criteria. Following surgical admission, standard monitoring was initiated, including continuous assessment of heart rate, blood pressure, electrocardiogram (ECG), and peripheral capillary oxygen saturation (SpO₂). A peripheral intravenous line was established. Bispectral index (BIS) monitoring was performed continuously using a BIS monitor to assess frontal lobe electroencephalographic activity. Based on the type of surgical procedure, regional nerve block was administered. Upon confirmation of adequate block efficacy, patients were assigned to treatment groups according to sealed envelope randomization, and corresponding intravenous sedative regimens were initiated. Sedative induction agents were administered as follows: Group A received remimazolam at 0.08 mg/kg; Group B received dexmedetomidine at 1 μg/kg over 10 minutes; Group C received midazolam at 0.05 mg/kg. Maintenance infusions were as follows: Group A received remimazolam at 1 mg/kg·h; Group B received dexmedetomidine at 0.2-0.7 μg/kg·h; for Group C, if consciousness was not sufficiently suppressed with the initial dose, midazolam was supplemented in increments of 0.01 mg/kg, not exceeding a total dose of 0.1 mg/kg. Following induction, sedation depth was assessed every 2 minutes using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, with auditory stimulation applied every 30 seconds until the patient no longer responded. The time to loss of response to auditory stimuli and the time to loss of consciousness were recorded. Surgical intervention was then performed. Ten minutes prior to anticipated completion of surgery, sedative infusion was discontinued. Sedation depth was reassessed every 2 minutes using the OAA/S scale, with repeated auditory stimulation every 30 seconds to determine the time to return of response and time to recovery of consciousness. If the patient had not achieved an OAA/S score of 5 within 30 minutes after discontinuation of sedation, flumazenil was administered as a reversal agent. Once the OAA/S score reached 5 or spontaneous responses to auditory stimuli were observed-indicating transition back to a responsive state-and complete electroencephalographic data had been collected, no further intervention was required.

Gender: All

Ages: 20 Years - 60 Years

Updated: 2026-03-12

EEG Data Analysis
Orthopedic Surgery
RECRUITING

NCT07339475

Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia

The study aims to assess whether the transverse diameter of the right common femoral vein (RCFV) in the inguinal region could reflect the degree of post-spinal hypotension during elective orthopedic surgery.

Gender: All

Ages: 60 Years - Any

Updated: 2026-01-14

Femoral Vein Diameter
Intraoperative Hypotension
Orthopedic Surgery
+1
NOT YET RECRUITING

NCT07117565

D-FAB-POUR Trial: Dexmedetomidine vs Fentanyl as Adjuvants to Bupivacaine on Postoperative Urinary Retention

This study aims to compare two medications, dexmedetomidine and fentanyl, when used alongside a commonly used spinal anesthetic called bupivacaine in patients undergoing lower limb surgery. The main focus of the study is to see which combination causes fewer problems with urination after surgery - a condition known as postoperative urinary retention (POUR). POUR can lead to discomfort, delayed recovery, and a need for catheterization. Dexmedetomidine is a newer drug that may help reduce this problem compared to fentanyl, which is more commonly used but may increase the risk of urinary retention. This trial will help determine which medication combination provides better pain relief while reducing urinary side effects. The study is being conducted as a randomized, double-blind trial at a hospital in Nepal and will include 190 adult patients. \-

Gender: All

Ages: 18 Years - 60 Years

Updated: 2025-08-12

1 state

Spinal Anesthesia
Postoperative Complications
Dexmedetomidine
+6
RECRUITING

NCT06995690

Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery

This randomized, double-blind, controlled clinical trial investigates the efficacy of a sub-anesthetic dose of ketamine (0.5 mg/kg IV) in preventing post-spinal hypotension in patients undergoing elective orthopedic surgeries under spinal anesthesia. The study compares ketamine with placebo (normal saline) in terms of blood pressure stability and incidence of hypotensive episodes following spinal anesthesia.

Gender: All

Ages: 18 Years - Any

Updated: 2025-06-18

Post-spinal Hypotension
Orthopedic Surgery
Spinal Aneshtesia
NOT YET RECRUITING

NCT06986408

Effect of Earplugs and Eye Masks Used After Orthopedic Surgery on Comfort and Quality of Recovery

This research will be conducted as a randomized controlled trial to determine the effects of earplugs and eye masks used after orthopedic surgery on comfort and quality of recovery. This study is a single-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted with 60 patients who underwent orthopedic surgery between June 2025 and October 2025. Participants will be randomized into two equal groups as the intervention group (n=30) and the control group (n=30). The patients in the experimental group will be administered the "Informed Consent Form" and the "Patient Introduction Form" after obtaining permission before surgery. Patients will be given an eye mask and earplugs on the nights following surgery and will be ensured to use them correctly. The "General Comfort Scale" and the "Quality of Recovery Questionnaire (Qor-40)" will be administered 24 and 48 hours after surgery. The patients in the control group will also be administered the "Informed Consent Form" and the "Patient Introduction Form" after obtaining permission before surgery. The "General Comfort Scale" and the "Quality of Recovery Questionnaire (Qor-40)" will be administered 24 and 48 hours after surgery. At the end of the study, the difference between the groups will be evaluated. In the analysis of this study, descriptive statistics, Shapiro-Wilk test, Chi-square test, t-test in independent groups, ANOVA test in repeated measures will be used. The main questions it aims to answer: Do earplugs and eye masks used after orthopedic surgery have an effect on comfort level? Do earplugs and eye masks used after orthopedic surgery have an effect on the quality of recovery?

Gender: All

Ages: 18 Years - Any

Updated: 2025-05-23

Orthopedic Surgery
Nursing Care
Quality of Recovery 40
+1
NOT YET RECRUITING

NCT06906120

The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery

This study aims to evaluate the effects of an operating room tour conducted using virtual reality (VR) goggles on anxiety, surgical fear, post-operative pain, satisfaction levels, and physiological parameters in patients undergoing orthopedic surgery. The intervention will involve a 360 degree educational video introducing the operating room environment, surgical team roles, and expected patient experience during the perioperative period. This video will be presented using Meta Quest 3 VR goggles. Participants in the intervention group will watch this video before surgery, while the control group will receive standard preoperative education. The primary outcomes include changes in preoperative anxiety (STAI-I), surgical fear (Surgical Fear Scale), and physiological parameters (e.g., heart rate, blood pressure, and electrodermal activity). Secondary outcomes include post-operative pain and patient satisfaction. Data will be collected at multiple time points, including before and after the intervention, on the day of surgery, and during the postoperative period. The study is designed as a randomized controlled trial with a sample size of 60 participants, equally distributed between intervention and control groups. Data analysis will include appropriate statistical tests based on variable distribution and group comparisons.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2025-04-18

2 states

Artroscopic Surgery
Orthopedic Surgery
ACTIVE NOT RECRUITING

NCT06904651

VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery

Our goal is to demonstrate how a standardized approach that involves the pre-operative implantation of the venous access devices in the DIVA patients (EA-DIVA score\> or =8), scheduled for orthopedic surgery, impacts both the intra- and post-operative safety of the patient and the economic savings of our institute. The latter would be achieved both through a reduction in operating room costs and in terms of recovery of operating room hours

Gender: All

Ages: 18 Years - Any

Updated: 2025-04-01

1 state

Midline Catheter
Orthopedic Surgery
ACTIVE NOT RECRUITING

NCT05716243

Nociception Level Index as a Verbal Tool of Pain in Children

60 children under 6 years old, scheduled for orthopedic surgery for limb fracture or neuromuscular and bone deformities will be randomized by closed envelope method into two groups (n=30) either receiving standard pain management protocol or intraoperative NOL guided analgesia. Our study aims to evaluate the nociception monitor's effectiveness in providing adequate postoperative analgesia in pediatric patients. Besides, the difference between the amount of analgesic medication will be recorded. Data to be recorded are total intraoperative morphine and postoperative rescue analgesic consumption, NOL values, and FLACC scores.

Gender: All

Ages: 1 Year - 6 Years

Updated: 2025-03-19

1 state

Pediatric Patients
Orthopedic Surgery
Extremity Fractures Lower
+2
ACTIVE NOT RECRUITING

NCT06838858

Effects of Motor Imagery Training After Muscle Lengthening Surgery in Children With Cerebral Palsy

In children with cerebral palsy (CP), spasticity occurs in the muscles due to upper motor neuron lesions. The muscle groups that are mostly spastic in the lower extremity are; the hip adductor and flexors, hamstrings, and ankle plantar flexors. Spasticity in the ankle plantar flexor muscles of these muscle groups causes contracture over time and restricts ankle dorsiflexion. Limitations in ankle dorsiflexion present as toe walking problems, balance loss, and various functional difficulties in children. Children with spasticity of the ankle plantar flexor muscles gastrocnemius and soleus are initially treated conservatively with exercise and positioning. However, after contracture occurs, treatment is performed using surgical methods. Surgical release of plantar flexor muscles is a method that has been proven to be effective and is frequently applied in the clinic. This surgery aims to remove the ankle dorsiflexion joint range of motion restriction, prevent toe walking, and improve the functional status of the child. However, since the plantar flexor muscles are in the antigravity muscle group, excessive release of these muscles can cause loss of balance and crouch gait. Therefore, it is important for this surgery to be performed by an experienced surgical team at the right time and to provide an exercise protocol aimed at stabilization by working both muscle groups in the postoperative period. In addition, after these surgeries, the patient is immobilized with a cast and orthosis for a while and the patient's active and passive movements are restricted with these devices. Motor Imagery; It is the process of learning a new movement or improving the quality of a known movement by visualizing it in a planned and intensive way in the mind of the person without performing any motor activity. This study hypothesized that the motor imagery training in the early rehabilitation process with movement restrictions after plantar flexor muscle relaxation operations will be effective on the patient's balance, walking, and quality of life.

Gender: All

Ages: 7 Years - 18 Years

Updated: 2025-03-12

Rehabilitation
Cerebral Palsy (CP)
Exercise
+3
RECRUITING

NCT05831345

Intraoperative Methadone for the Prevention of Postoperative Pain

The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively. Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed. It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient. Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.

Gender: All

Ages: 18 Years - 80 Years

Updated: 2025-02-07

Orthopedic Surgery
RECRUITING

NCT05760339

Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

The purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.

Gender: All

Ages: 18 Years - Any

Updated: 2024-10-22

1 state

Perioperative Care
Intermittent Fasting
Carbohydrate Loading
+3
NOT YET RECRUITING

NCT06638658

Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions

This study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. Regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. The ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.

Gender: All

Ages: 18 Years - Any

Updated: 2024-10-15

Orthopedic Surgery
Postoperative Complications
High Altitude
NOT YET RECRUITING

NCT06497634

Effect of Spinal Needle Type on Optic Nerve Sheath Diameter

The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter of the optic nerve sheath, which is coreleted with intracranial pressure. Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. Optic nerve sheath diameter (ONSD) measurements will be performed before spinal anesthesia; and 5 minutes, 15 minutes,,24 hours after spinal block, respectively.The 4th measurement will be performed after tourniquet is opened. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes, on upper eyelid. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.

Gender: All

Ages: 18 Years - 40 Years

Updated: 2024-07-30

1 state

Spinal Anesthesia
Intracranial Pressure Change
Optic Nerve Sheath Diameter
+2