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Brain Neoplasms | Small-dose Dexmedetomidine Effects on Recovery Profiles of Supratentorial Tumors Patients From General Anesthesia

Brain Neoplasms research study

What is the primary objective of this study?

An excellent recovery profile is critical for neurosurgical anesthesia. Rapid awakening, smooth blood pressure and heart rate (HR), a higher degree of coordination, painless or mild pain, as well as better tolerance to endotracheal intubation can avoid can increased intracranial pressure, elevated blood pressure and rapid HR caused by emergency choking, suffocation and agitation, and can reduce postoperative cerebral edema and the risk of bleeding. In addition, it is easy for surgeons to timely evaluate postoperative patients' neurologic function based on the excellent recovery from anesthesia. Up to now, there are many methods and drugs to improve the quality of recovery period, but each of them has some flaws. Dexmedetomidine, an emerging anesthetic adjuvant, exhibits a stable hemodynamic recovery period, and cannot affect evaluation of neurological function with both the sedative and analgesic effects. We propose the following hypotheses: (1) A small dose of dexmedetomidine can be intravenously injected into patients subjected to craniotomy under general anesthesia, in order to improve the recovery profiles and reduce the incidence of emergence agitation. (2) Dexmedetomidine can reduce postoperative pain.

Who is eligible to participate?

Inclusion Criteria: - American society of anesthesiologist class (ASA) I ASA II: patient with mild systemic disease; no functional limitation);Preoperative MRI diagnosis of supratentorial lesions (glioma, meningioma or neurofibroma), and tumor diameter <= 40 mm;The subject gets full score for Glasgow Coma Score;Estimated operation time <= 6 hours and anesthesia time <= 8 hours;The subject has given written informed consent. Exclusion Criteria: - The subject has participated in other clinical trials at 4 weeks before the beginning of the present study;The subject is taking or has taken β-blockers (such as metoprolol) within 2 weeks before the beginning of the present study;The subject has undergone craniotomy twice or more;The subject has a history of sinus bradycardia (preoperative electrocardiogram of HR <= 50 beats/min), sick sinus syndrome, myocardial infarction, Ⅱ grade and grade Ⅱ cardiac function, and severe hypertension (systolic blood pressure (SBP)> = 180 mmHg or diastolic blood pressure (DBP)> = 110 mmHg);The subject has a history of lung disease (blood oxygen content <95% when breathing air at an awake state);The subject has a history of liver dysfunction (1.5 times or more that of the normal value);The subject has a history of kidney dysfunction (levels of serum creatinine and blood urea nitrogen are out of the normal range);Hypersensitivity to dexmedetomidine;Tolerance to dexmedetomidine;The subject has a history of drugs or alcohol abuse;The weight exceeds ±15% of standard weight range, and the standard weight is calculated as the following formula: standard weight=body height (cm)-100;Pregnant or lactating women;The subject is considered unsuitable for this trial.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Brain Neoplasms

Surgery

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:dexmedetomidine2 ml of dexmedetomidine at a concentration of 100 ug/ml is diluted by 98 ml normal saline to a concentration of 2 ug/ml. The required amount of experimental drugs is confirmed according to the weight and grouping, and diluted using normal saline to 20 ml.

Drug:normal saline100 ml per bag

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

low-dose groupS group : dexmedetomidine is infused intravenously at a dose of 0.4 ug/kg

middle-dose groupM group: dexmedetomidine is infused intravenously at a dose of 0.8 ug/kg

control groupP group: normal saline is infused intravenously

Study Status

Unknown status

Start Date: January 2014

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Hemodynamic impacts

Secondary Outcome: Time of recovery from anesthesia

Study sponsors, principal investigator, and references

Principal Investigator: Ling Pei

Lead Sponsor: China Medical University, China

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02007798

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