- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552459
Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery
October 16, 2016 updated by: Xinxin Shao, First Affiliated Hospital, Sun Yat-Sen University
Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study
The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liu Yi, master
- Phone Number: +86 13632391455
- Email: liuyisysu@126.com
Study Contact Backup
- Name: Jiang nan, doctor
- Phone Number: +86 13725407606
- Email: jiangnanshen@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- the First Affiliated Hospital of Sun Yetsen University
-
Contact:
- Yi Liu, Master
- Phone Number: +86 13632391455
- Email: liuyisysu@126.com
-
Contact:
- Nan Jiang, professor
- Phone Number: +86 20 28823350
- Email: NJiang_sysu@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sufentanil
sufentanil 150μg,intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Names:
|
Experimental: sufentanil&dexmedetomidine 1
sufentanil 150μg,dexmedetomidine 0.05μg/kg/h,intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Names:
dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation
Other Names:
|
Experimental: sufentani&dexmedetomidine 2
sufentanil 150μg,dexmedetomidine 0.1μg/kg/h,intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Names:
dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation
Other Names:
|
Experimental: sufentanil&dexmedetomidine 3
sufentanil 150μg,dexmedetomidine 0.15μg/kg/h ,intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Names:
dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on the VAS scale
Time Frame: within the following 72 hours after surgery
|
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)
Time Frame: 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
|
within the following 72 hours after surgery
|
heart rate(HR) (/min)
Time Frame: 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
|
within the following 72 hours after surgery
|
spO2(%)
Time Frame: 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
|
within the following 72 hours after surgery
|
breath(/min)
Time Frame: 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
|
within the following 72 hours after surgery
|
sedation level on ramsay sedation score
Time Frame: 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
|
within the following 72 hours after surgery
|
vomit times
Time Frame: 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
|
within the following 72 hours after surgery
|
nausea
Time Frame: 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
|
within the following 72 hours after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dose of rescue tramadol
Time Frame: within the following 72 hours after surgery
|
measure the dose of tramadol using as rescue drug on post-operative 24h、48h、72h
|
within the following 72 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jiang Nan, doctor, The First Affiliated Hospital, Sun Yat-sen Unniversity
- Principal Investigator: Shao Xinxin, master, The First Affiliated Hospital, Sun Yat-sen Unniversity
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
May 26, 2015
First Submitted That Met QC Criteria
September 16, 2015
First Posted (Estimate)
September 17, 2015
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 16, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Dexmedetomidine
- Sufentanil
- Dsuvia
Other Study ID Numbers
- FirstSunYetSen-jn2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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