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

NCT ID: NCT02552459

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

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.

Conditions

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Arteriovenous Malformation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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sufentanil

sufentanil 150μg,intravenous administration during the following 72 hours after operation.

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

sufentanil 150μg, intravenous administration during post-operative 72 hours.

sufentanil&dexmedetomidine 1

sufentanil 150μg,dexmedetomidine 0.05μg/kg/h,intravenous administration during the following 72 hours after operation.

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

sufentanil 150μg, intravenous administration during post-operative 72 hours.

dexmedetomidine 1

Intervention Type DRUG

dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation

sufentani&dexmedetomidine 2

sufentanil 150μg,dexmedetomidine 0.1μg/kg/h,intravenous administration during the following 72 hours after operation.

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

sufentanil 150μg, intravenous administration during post-operative 72 hours.

dexmedetomidine 2

Intervention Type DRUG

dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation

sufentanil&dexmedetomidine 3

sufentanil 150μg,dexmedetomidine 0.15μg/kg/h ,intravenous administration during the following 72 hours after operation.

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

sufentanil 150μg, intravenous administration during post-operative 72 hours.

dexmedetomidine 3

Intervention Type DRUG

dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.

Interventions

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Sufentanil

sufentanil 150μg, intravenous administration during post-operative 72 hours.

Intervention Type DRUG

dexmedetomidine 1

dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation

Intervention Type DRUG

dexmedetomidine 2

dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation

Intervention Type DRUG

dexmedetomidine 3

dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.

Intervention Type DRUG

Other Intervention Names

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Sufentanyl Dex,Dexmedetomidine Dex,Dexmedetomidine Dex,Dexmedetomidine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Xinxin Shao

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiang Nan, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Sun Yat-sen Unniversity

Shao Xinxin, master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Sun Yat-sen Unniversity

Locations

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the First Affiliated Hospital of Sun Yetsen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu Yi, master

Role: CONTACT

13632391455 ext. +86

Jiang nan, doctor

Role: CONTACT

13725407606 ext. +86

Facility Contacts

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Yi Liu, Master

Role: primary

+86 13632391455

Nan Jiang, professor

Role: backup

+86 20 28823350

Other Identifiers

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FirstSunYetSen-jn2015

Identifier Type: -

Identifier Source: org_study_id

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