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Intraoperative Complications clinical trials

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NCT ID: NCT06450834 Not yet recruiting - Clinical trials for Postoperative Complications

Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

Ostene VIBe
Start date: June 2024
Phase:
Study type: Observational

In spine surgery, it is important to try to minimize bleeding. In particular, spine surgery often involves inserting hardware into bone, and/or removing bone in the spine. Because the bone in the spine contains blood vessels, there can often be bleeding from the bone itself that is difficult to stop completely. One way to stop bone bleeding is through the use of wax-like materials, which plug the bleeding bone and act as a physical barrier to stop bleeding. One example is Ostene bone hemostasis material, which has the advantage of being "water soluble", meaning it will dissolve naturally over time. The purpose of this study is to evaluate how well Ostene does at decreasing bleeding, by using a recognized scale called the validated intraoperative bleeding severity scale, abbreviated as "VIBe". In this study, the investigators will record the bleeding severity throughout multiple time points in surgery using this scale, and then the investigators will compare the measurements to patients in the past who did not receive Ostene. Overall, this research will help measure how well Ostene decreases bleeding.

NCT ID: NCT06257316 Not yet recruiting - Hypotension Clinical Trials

Appropriate Dosage of Vasopressor in Neonates and Infants

Start date: February 15, 2024
Phase: Phase 4
Study type: Interventional

In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia.

NCT ID: NCT05638152 Not yet recruiting - Pain, Postoperative Clinical Trials

Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery

SPACU-lab
Start date: May 1, 2023
Phase:
Study type: Observational

Rationale: Surgical trauma and post-surgical pain induce a physiological stress response that can be detrimental to the patient. Non-pharmacological interventions aimed at stress reduction are known to reduce pain scores and opioid consumption. The effect of these interventions on the surgical stress response are unknown. Objective: To assess the effect of a bundle of non-pharmacological interventions implemented in the post-anesthesia care unit on the total serum cortisol levels after intermediate and major surgery. Study design: This is a prospective before-after study. Study population: Patients scheduled for intermediate or major oncological surgery in a tertiary referral cancer center. Intervention: The implementation of a bundle of four non-pharmacological interventions aimed at stress reduction in the post-anesthesia care unit. The bundle consists of: access to music, aromatherapy, natural images on the walls and ceiling and communication techniques aimed at reduction of stress and pain. Main study parameters/endpoints: Serum cortisol levels on the first postoperative day.

NCT ID: NCT05237700 Not yet recruiting - Clinical trials for Peripheral Neuropathy

Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table.

Start date: February 2022
Phase:
Study type: Observational

Robotic assisted laparoscopic and laparoscopic gynecological, colon-rectal and urological surgical procedures require that patients be placed in steep Trendelenburg positioning with or without lithotomy on operating table. Steep Trendelenburg positioning is a variation of supine positioning in which the patient lies face up with the head and body tilted 250-450 downwards. In lithotomy position the legs are placed in stirrups and knees bent flexing the leg on the operating table. Lithotomy position can be graded in four levels according to what access the surgeon needs. The arms are tucked and padded parallel to the body, or the arms left on an arm board at an angel of less 900. Intraoperative peripheral nerve injury (IPNI) may follow incorrect positioning, inadequate fixation, or prolonged time in positioning. IPNI is defined as new (within 48 h) sensory and/or motor deficits and occurs following a combination of stretch, ischemia and/or compression during surgery and the injuries are either temporary or permanent. In a systematic review we found that IPNI was related to lithotomy positioning with steep Trendelenburg in upper and lower extremity and the incidence of IPNI ranges from 0.16% to 10 %. IPNI after patient positioning on operating table has been described to result in pain and other symptoms as numbness, weakness, and tingling. As demonstrated in our systematic review many of the patients with IPNI did not report pain, which also supported in a recent review. In addition, our systematic review showed that the symptoms appeared immediately after surgical procedures and usually subside within three months. The systematic review also demonstrates that a few patients continue to have pain or/and other symptoms of IPNI up to one year following the surgery. Furthermore, previous studies have demonstrated that pain intensity and duration of pain influence daily activities and quality of life negatively. Positioning of the patients on operating table is a teamwork where the operating room nurse (ORN) has a pivotal role in order to protect the patients from experiencing injuries due to e.g. nerve compression and compromised circulation. The purpose of this study is to increase the knowledge of IPNI related to positioning in patients undergoing robotic-assisted laparoscopic surgery and laparoscopic surgery. As IPNI is an unclear phenomenon that can be difficult to diagnose, we want to identify pain and other symptoms immediately after surgery that might have an impact on development of IPNI. Several studies have reported persistent pain after surgery like neuropathic pain and that neuropathic pain occur soon after nerve lesion. To get at a broader picture of IPNI we want to explore pain and other symptoms and to characterize how these symptoms might change, and to identify risk factors associated with IPNI. Therefore, the aims of the present study are: 1. Identify the incidence of IPNI up to 12 months after surgery. 2. Explore pain, other symptoms, physical function and quality of life up to 12 months after surgery. 3. Explore risk factors associated with IPNI. 4. Explore associations between IPNI and quality of life.

NCT ID: NCT04256928 Not yet recruiting - Clinical trials for Intraoperative Complications

The Effect of Hair Removal on Intraoperative Contamination

Start date: February 15, 2020
Phase: N/A
Study type: Interventional

A prospective, non-blinded, randomized controlled trial with the purpose of investigating, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination. The primary investigators hypothesis is this: Preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination. 200 male participants, 18 years or older, with a planned primary knee replacement surgery, will be enrolled. During surgery, four microbiological samples will be taken from each participant. The primary outcome is whether there is intraoperative contamination of the surgical site or not, determined by identification of any grown bacteria from the samples. If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will provide a cost-effective method of reducing the risk of intraoperative contamination and consequent postoperative infection, a solid argument for a change of current guidelines for preoperative hair removal, and provide additional information pointing towards body hair as a possible explanation for the increased infection rate in men.