Arteriovenous Malformation
Conditions
Keywords
dexmedetomidine, patient controlled analgesia
Brief summary
The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.
Detailed description
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.
Interventions
DRUGSufentanil
sufentanil 150μg， intravenous administration during post-operative 72 hours.
dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation
dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation
DRUGdexmedetomidine 3
dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. patients undergoing venous malformation embolization operation through general anesthesia. 2. aged 18-65 years old. 3. operating time varies 1-4h,and extubation after the operation.
Exclusion criteria
1. long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history. 2. known for dexmedetomidine or other drugs allergy in this study. 3. cannot communicate. 4. preoperative systolic blood pressure \<90 mmHg, or the heart rate \<50/min.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on the VAS scale | within the following 72 hours after surgery | measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure(BP)(mmHg) | within the following 72 hours after surgery | measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h |
| heart rate(HR) (/min) | within the following 72 hours after surgery | measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h |
| spO2(%) | within the following 72 hours after surgery | measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h |
| sedation level on ramsay sedation score | within the following 72 hours after surgery | measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h |
| vomit times | within the following 72 hours after surgery | 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 |
| nausea | within the following 72 hours after surgery | 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 |
| breath(/min) | within the following 72 hours after surgery | measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h |
Other
| Measure | Time frame | Description |
|---|---|---|
| dose of rescue tramadol | within the following 72 hours after surgery | measure the dose of tramadol using as rescue drug on post-operative 24h、48h、72h |
Countries
China
Contacts
Primary ContactLiu Yi, master
Backup ContactJiang nan, doctor
Outcome results
None listed