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

Primary Purpose

Arteriovenous Malformation

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Sufentanil

dexmedetomidine 1

dexmedetomidine 2

dexmedetomidine 3

About this trial

This is an interventional treatment trial for Arteriovenous Malformation focused on measuring dexmedetomidine, patient controlled analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

the First Affiliated Hospital of Sun Yetsen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

sufentanil

sufentanil&dexmedetomidine 1

sufentani&dexmedetomidine 2

sufentanil&dexmedetomidine 3

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Pain on the VAS scale

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

Secondary Outcome Measures

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

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

spO2(%)

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)

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 score

measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h

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

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

Full Information

NCT ID

NCT02552459

First Posted

May 26, 2015

Last Updated

October 16, 2016

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT02552459

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arteriovenous Malformation

Keywords

dexmedetomidine, patient controlled analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sufentanil

Arm Type

Active Comparator

Arm Description

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

Arm Title

sufentanil&dexmedetomidine 1

Arm Type

Experimental

Arm Description

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

Arm Title

sufentani&dexmedetomidine 2

Arm Type

Experimental

Arm Description

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

Arm Title

sufentanil&dexmedetomidine 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sufentanil

Other Intervention Name(s)

Sufentanyl

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

dexmedetomidine 1

Other Intervention Name(s)

Dex,Dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

dexmedetomidine 2

Other Intervention Name(s)

Dex,Dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

dexmedetomidine 3

Other Intervention Name(s)

Dex,Dexmedetomidine

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain on the VAS scale

Description

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

Time Frame

within the following 72 hours after surgery

Secondary Outcome Measure Information:

Title

blood pressure(BP)(mmHg)

Description

measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h

Time Frame

within the following 72 hours after surgery

Title

heart rate(HR) (/min)

Description

measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h

Time Frame

within the following 72 hours after surgery

Title

spO2(%)

Description

measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h

Time Frame

within the following 72 hours after surgery

Title

breath(/min)

Description

measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h

Time Frame

within the following 72 hours after surgery

Title

sedation level on ramsay sedation score

Description

measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h

Time Frame

within the following 72 hours after surgery

Title

vomit times

Description

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

Time Frame

within the following 72 hours after surgery

Title

nausea

Description

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

Time Frame

within the following 72 hours after surgery

Other Pre-specified Outcome Measures:

Title

dose of rescue tramadol

Description

measure the dose of tramadol using as rescue drug on post-operative 24h、48h、72h

Time Frame

within the following 72 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liu Yi, master

Phone

13632391455

Ext

+86

liuyisysu@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jiang nan, doctor

Phone

13725407606

Ext

+86

jiangnanshen@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiang Nan, doctor

Organizational Affiliation

The First Affiliated Hospital, Sun Yat-sen Unniversity

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shao Xinxin, master

Organizational Affiliation

The First Affiliated Hospital, Sun Yat-sen Unniversity

Official's Role

Principal Investigator

Facility Information:

Facility Name

the First Affiliated Hospital of Sun Yetsen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Liu, Master

Phone

+86 13632391455

liuyisysu@126.com

First Name & Middle Initial & Last Name & Degree

Nan Jiang, professor

Phone

+86 20 28823350

NJiang_sysu@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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