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The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.
Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sufentanil | Active Comparator | sufentanil 150μg，intravenous administration during the following 72 hours after operation. |
|
| sufentanil&dexmedetomidine 1 | Experimental | sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation. |
|
| sufentani&dexmedetomidine 2 | Experimental | sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation. |
|
| sufentanil&dexmedetomidine 3 | Experimental | sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil | Drug | sufentanil 150μg， intravenous administration during post-operative 72 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain on the VAS scale | measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。 | within the following 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure(BP)(mmHg) | measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h | within the following 72 hours after surgery |
| heart rate(HR) (/min) |
| Measure | Description | Time Frame |
|---|---|---|
| dose of rescue tramadol | measure the dose of tramadol using as rescue drug on post-operative 24h、48h、72h | within the following 72 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Yi, master | Contact | 13632391455 | +86 | liuyisysu@126.com |
| Jiang nan, doctor | Contact | 13725407606 | +86 | jiangnanshen@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Nan, doctor | The First Affiliated Hospital, Sun Yat-sen Unniversity | Principal Investigator |
| Shao Xinxin, master | The First Affiliated Hospital, Sun Yat-sen Unniversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Sun Yetsen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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|
| dexmedetomidine 1 | Drug | dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation |
|
|
| dexmedetomidine 2 | Drug | dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation |
|
|
| dexmedetomidine 3 | Drug | dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h. |
|
|
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
| within the following 72 hours after surgery |
| spO2(%) | measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h | within the following 72 hours after surgery |
| breath(/min) | measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h | within the following 72 hours after surgery |
| sedation level on ramsay sedation score | measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h | within the following 72 hours after surgery |
| vomit times | measure vomit times on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h | within the following 72 hours after surgery |
| nausea | measure whether nausea exists on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h | within the following 72 hours after surgery |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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