Clinical trial · Interventional
Small-dose Dexmedetomidine Effects on Recovery Profiles of Supratentorial Tumors Patients From General Anesthesia
Randomized, Parallelled and Double-blinded Trial of Small-dose Dexmedetomidine Effects on Recovery Profiles of Supratentorial Tumors Patients From General Anesthesia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexmedetomidine | Drug | — | UNRESOLVED |
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- low-dose group
- description
- S group : dexmedetomidine is infused intravenously at a dose of 0.4 ug/kg
- interventionNames
- Drug: dexmedetomidine
- type
- EXPERIMENTAL
- label
- middle-dose group
- description
- M group: dexmedetomidine is infused intravenously at a dose of 0.8 ug/kg
- interventionNames
- Drug: dexmedetomidine
- type
- EXPERIMENTAL
- label
- control group
- description
- P group: normal saline is infused intravenously
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * American society of anesthesiologist class (ASA) I \& II (ASA I: normal healthy patient; 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.
References
Publications (0)
Data not yet available