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

Registration Number
NCT02552459
Lead Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
120
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
sufentanil&dexmedetomidine 1dexmedetomidine 1sufentanil 150μg,dexmedetomidine 0.05μg/kg/h,intravenous administration during the following 72 hours after operation.
sufentani&dexmedetomidine 2dexmedetomidine 2sufentanil 150μg,dexmedetomidine 0.1μg/kg/h,intravenous administration during the following 72 hours after operation.
sufentanil&dexmedetomidine 3dexmedetomidine 3sufentanil 150μg,dexmedetomidine 0.15μg/kg/h ,intravenous administration during the following 72 hours after operation.
sufentanilSufentanilsufentanil 150μg,intravenous administration during the following 72 hours after operation.
sufentani&dexmedetomidine 2Sufentanilsufentanil 150μg,dexmedetomidine 0.1μg/kg/h,intravenous administration during the following 72 hours after operation.
sufentanil&dexmedetomidine 1Sufentanilsufentanil 150μg,dexmedetomidine 0.05μg/kg/h,intravenous administration during the following 72 hours after operation.
sufentanil&dexmedetomidine 3Sufentanilsufentanil 150μg,dexmedetomidine 0.15μg/kg/h ,intravenous administration during the following 72 hours after operation.
Primary Outcome Measures
NameTimeMethod
Pain on the VAS scalewithin the following 72 hours after surgery

measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。

Secondary Outcome Measures
NameTimeMethod
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

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

sedation level on ramsay sedation scorewithin 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 timeswithin 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

nauseawithin 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

Trial Locations

Locations (1)

the First Affiliated Hospital of Sun Yetsen University

🇨🇳

Guangzhou, Guangdong, China

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