Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study

Conditions
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Arteriovenous Malformation

Intervention / Treatment
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* Drug: Sufentanil
* Drug: dexmedetomidine 1
* Drug: dexmedetomidine 2
* Drug: dexmedetomidine 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing venous malformation embolization operation through general anesthesia. aged 18-65 years old. operating time varies 1-4h,and extubation after the operation. Exclusion Criteria: long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history. known for dexmedetomidine or other drugs allergy in this study. cannot communicate. preoperative systolic blood pressure <90 mmHg, or the heart rate <50/min.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sufentanil<br>sufentanil 150μg，intravenous administration during the following 72 hours after operation. | Drug: Sufentanil<br>* sufentanil 150μg， intravenous administration during post-operative 72 hours.<br>* Other names: Sufentanyl;|
| Experimental: sufentanil&dexmedetomidine 1<br>sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation. | Drug: Sufentanil<br>* sufentanil 150μg， intravenous administration during post-operative 72 hours.<br>* Other names: Sufentanyl;Drug: dexmedetomidine 1<br>* dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation<br>* Other names: Dex,Dexmedetomidine;|
| Experimental: sufentani&dexmedetomidine 2<br>sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation. | Drug: Sufentanil<br>* sufentanil 150μg， intravenous administration during post-operative 72 hours.<br>* Other names: Sufentanyl;Drug: dexmedetomidine 2<br>* dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation<br>* Other names: Dex,Dexmedetomidine;|
| Experimental: sufentanil&dexmedetomidine 3<br>sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation. | Drug: Sufentanil<br>* sufentanil 150μg， intravenous administration during post-operative 72 hours.<br>* Other names: Sufentanyl;Drug: dexmedetomidine 3<br>* dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.<br>* Other names: Dex,Dexmedetomidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, patient controlled analgesia