Craniotomy

8

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

Condition / disease
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Status: Not yet recruiting

an Analgesia-first Strategy Without Hypnotic Sedatives in Adult Patients Admitted to the Intensive Care Unit After Neurosurgical Craniotomy

Analgesia and sedation are core components of intensive care unit (ICU) care. They are used to relieve pain and anxiety, prevent harmful physiological stress responses, improve tolerance of invasive devices and mechanical ventilation, and reduce noxious stimulation. Contemporary ICU practice has moved away from deep continuous sedation toward analgesia-first care, lighter sedation targets, delirium prevention, early mobilization, and patient-centred comfort strategies. Patients admitted to the ICU after neurosurgical craniotomy pose a specific challenge. Postoperative agitation after intracranial surgery may lead to unplanned extubation, catheter or drain removal, injury, hypertension, coughing, increased sympathetic activation, and potentially adverse neurological consequences. The incidence of agitation after elective intracranial operations was 29%, which was higher than that previously observed in other surgical populations. Neurosurgical patients may be more vulnerable to stress caused by agitation, due to longer anesthesia duration, delayed extubation and pain and post-craniotomy frontal pneumocephalus. Brain lesions and intracranial manipulations in neurosurgical patients might affect the brain regions which involves cognition and emotion, and are assumed to influence postoperative cognition. At the same time, excessive hypnotic sedation may obscure level of consciousness, pupillary and focal neurological examinations, early seizures, intracranial hypertension, or surgical complications. Previous neurosurgical studies have reported postoperative agitation and delirium after craniotomy were not rare, and risk factors including longer anesthesia duration, delayed extubation, pain, and postoperative pneumocephalus have been reported. However, the investigations of analgesia and sedation in neurosurgical populations have been inadequate. Most of the researches about analgesia and sedation in general ICU were excluded the neurosurgical patients. These patients are special for its cruciality of evaluating the consciousness and neurological signs examination. The analgesia and sedation management is difficult and complex. Several general ICU studies support interest in minimizing routine hypnotic sedation. In a single-centre randomized trial, a protocol of no sedation with morphine boluses increased ventilator-free days and shortened ICU and hospital stay compared with sedation and daily interruption, although agitated delirium was more frequent. In the larger multicentre NONSEDA trial, mortality at 90 days did not differ significantly between nonsedation and light sedation with daily interruption, and many patients in the nonsedation group still required sedatives during ICU stay, most commonly because of delirium. Related NONSEDA substudies have also emphasized that the effects of nonsedation on physical function and cognition require dedicated evaluation. These findings cannot be directly transferred to post-craniotomy neurocritical care. Reviews, consensus statements and observational studies in neurocritical care emphasize with brain-injured patients have unique sedation indications, including control of intracranial pressure, seizures, cerebral oxygen consumption, ventilator synchrony, and severe agitation. Observational data from brain-injury ICUs show wide variation in sedative and analgesic practice and support structured use of sedation and pain scales. Expert consensus also supports administering analgesics before sedatives when clinically appropriate, but acknowledges the limited high-quality evidence in this population. Therefore, an analgesia-first strategy without routine hypnotic sedatives should be evaluated cautiously with explicit neurological safety monitoring and rescue criteria. Remifentanil is a short-acting opioid with rapid onset and offset because it is metabolized by non-specific blood and tissue esterases. These pharmacological features make it suitable for titrated analgesia when repeated neurological assessment is needed. We therefore designed this single-arm exploratory study to estimate the feasibility and safety of a remifentanil-based analgesia-first strategy without routine hypnotic sedatives in selected adult patients admitted to ICU after neurosurgical craniotomy.

Participants needed: 65
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Beijing Tiantan HospitalUpdated: May 28, 2026Locations: 1
Eligibility criteria

Age 18-85 years; [+4]

Need for deep sedation or therapeutic coma, including (partial pressure of oxyge... [+13]

Status: Recruiting

Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors

Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Medical University of WarsawUpdated: May 22, 2026Locations: 1Duration: 6 Weeks
Eligibility criteria

Male or female at least 18 years old [+1]

Revision surgery due to recurrent brain tumor [+1]

Status: Not yet recruiting

Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware

The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.

Participants needed: 204
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: RevBioUpdated: Mar 5, 2026
Eligibility criteria

Subject, and/or subject's family are able and willing to provide informed consen... [+5]

Subject has undergone a previous, open intracranial neurosurgical procedure in t... [+10]

Status: Recruiting

Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia

This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia.

Participants needed: 36
Trial details
Age: 18-40Biological sex: AllType: ObservationalSponsor: Ain Shams UniversityUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Age from 18 to 40 years. [+5]

Current or recent pregnancy (within 3 months). [+3]

Status: Recruiting

Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases

This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.

Participants needed: 2,000
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: RenJi HospitalUpdated: Jan 14, 2026Locations: 1Duration: 6 Months
Eligibility criteria

Clear medical history of traumatic brain injury; [+4]

Previous intracranial surgery prior to trauma; [+5]

Status: Recruiting

Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy

This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.

Participants needed: 50
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Ain Shams UniversityUpdated: May 30, 2025Locations: 1
Eligibility criteria

Age from 18 to 65 years. [+3]

Patients refusal. [+6]

Status: Recruiting

Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage. Differences in outcome between surgical treatment and endovascular treatment will be explored. Furthermore, cost effectiveness and radiological prognostic factors will be examined.

Participants needed: 880
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Haaglanden Medical CentreUpdated: Mar 25, 2025Locations: 6
Eligibility criteria

Confirmed diagnosis of subarachnoid haemorrhage on CT-scan or lumbar puncture (i... [+3]

Subarachnoid haemorrhage deemed most likely of 'perimesencephalic' origin after... [+4]

Status: Recruiting

A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive

This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.

Participants needed: 15
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: RevBioUpdated: Mar 11, 2025Locations: 1
Eligibility criteria

Subjects can be any gender, but be between (and including) 18 and 75 years of ag... [+5]

Subject requires a procedure involving a translabyrinthine, transsphenoidal, tra... [+10]