Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00741351
Eligibility Criteria:
Inclusion criteria:
* Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours;
* Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease);
* Age 18-75 years;
* Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;
* No signs of intracranial hypertension.
Exclusion criteria:
* Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve.
* Renal or liver disease precluding the use of either anesthetic technique.
* Pregnancy .
* Known allergies to any anesthetic agent.
* Reduced preoperative level of consciousness, i.e.
* Glasgow Coma Scale (GCS) \< 15.
* Body weight greater than 120 kg.
* History of drug abuse or psychiatric conditions.
* Documented disturbance of the hypothalamic region.Refusal to sign consent form.
* Participation in other clinical trials.
* Delayed awakening, because, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00741351
Study Brief:
Protocol Section:
NCT00741351