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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02552459
Recruitment Status : Unknown
Verified October 2016 by Xinxin Shao, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : September 17, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Xinxin Shao, 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.

Condition or disease Intervention/treatment Phase
Arteriovenous Malformation Drug: Sufentanil Drug: dexmedetomidine 1 Drug: dexmedetomidine 2 Drug: dexmedetomidine 3 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: sufentanil
sufentanil 150μg,intravenous administration during the following 72 hours after operation.
Drug: Sufentanil
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Name: Sufentanyl

Experimental: sufentanil&dexmedetomidine 1
sufentanil 150μg,dexmedetomidine 0.05μg/kg/h,intravenous administration during the following 72 hours after operation.
Drug: Sufentanil
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Name: Sufentanyl

Drug: dexmedetomidine 1
dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation
Other Name: Dex,Dexmedetomidine

Experimental: sufentani&dexmedetomidine 2
sufentanil 150μg,dexmedetomidine 0.1μg/kg/h,intravenous administration during the following 72 hours after operation.
Drug: Sufentanil
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Name: Sufentanyl

Drug: dexmedetomidine 2
dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation
Other Name: Dex,Dexmedetomidine

Experimental: sufentanil&dexmedetomidine 3
sufentanil 150μg,dexmedetomidine 0.15μg/kg/h ,intravenous administration during the following 72 hours after operation.
Drug: Sufentanil
sufentanil 150μg, intravenous administration during post-operative 72 hours.
Other Name: Sufentanyl

Drug: dexmedetomidine 3
dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.
Other Name: Dex,Dexmedetomidine




Primary Outcome Measures :
  1. 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。


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552459


Contacts
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Contact: Liu Yi, master 13632391455 ext +86 liuyisysu@126.com
Contact: Jiang nan, doctor 13725407606 ext +86 jiangnanshen@126.com

Locations
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China, Guangdong
the First Affiliated Hospital of Sun Yetsen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yi Liu, Master    +86 13632391455    liuyisysu@126.com   
Contact: Nan Jiang, professor    +86 20 28823350    NJiang_sysu@126.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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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

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Responsible Party: Xinxin Shao, resident, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02552459    
Other Study ID Numbers: FirstSunYetSen-jn2015
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by Xinxin Shao, First Affiliated Hospital, Sun Yat-Sen University:
dexmedetomidine
patient controlled analgesia
Additional relevant MeSH terms:
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Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Sufentanil
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics