NCT02552459

Brief Summary

The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

May 26, 2015

Last Update Submit

October 16, 2016

Conditions

Arteriovenous Malformation

Keywords

dexmedetomidinepatient controlled analgesia

Outcome Measures

Primary Outcomes (1)

  • Pain on the VAS scale

    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 Outcomes (7)

  • blood pressure(BP)(mmHg)

    within the following 72 hours after surgery

  • heart rate(HR) (/min)

    within the following 72 hours after surgery

  • spO2(%)

    within the following 72 hours after surgery

  • breath(/min)

    within the following 72 hours after surgery

  • sedation level on ramsay sedation score

    within the following 72 hours after surgery

  • +2 more secondary outcomes

Other Outcomes (1)

  • dose of rescue tramadol

    within the following 72 hours after surgery

Study Arms (4)

sufentanil

ACTIVE COMPARATOR

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

Drug: Sufentanil

sufentanil&dexmedetomidine 1

EXPERIMENTAL

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

Drug: SufentanilDrug: dexmedetomidine 1

sufentani&dexmedetomidine 2

EXPERIMENTAL

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

Drug: SufentanilDrug: dexmedetomidine 2

sufentanil&dexmedetomidine 3

EXPERIMENTAL

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

Drug: SufentanilDrug: dexmedetomidine 3

Interventions

SufentanilDRUG

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

Also known as: Sufentanyl
sufentani&dexmedetomidine 2sufentanilsufentanil&dexmedetomidine 1sufentanil&dexmedetomidine 3
dexmedetomidine 1DRUG

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

Also known as: Dex,Dexmedetomidine
sufentanil&dexmedetomidine 1
dexmedetomidine 2DRUG

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

Also known as: Dex,Dexmedetomidine
sufentani&dexmedetomidine 2
dexmedetomidine 3DRUG

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

Also known as: Dex,Dexmedetomidine
sufentanil&dexmedetomidine 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing venous malformation embolization operation through general anesthesia.
  • aged 18-65 years old.
  • operating time varies 1-4h,and extubation after the operation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Sun Yetsen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Arteriovenous Malformations

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jiang Nan, doctor

    The First Affiliated Hospital, Sun Yat-sen Unniversity

    PRINCIPAL INVESTIGATOR

  • Shao Xinxin, master

    The First Affiliated Hospital, Sun Yat-sen Unniversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Yi, master

CONTACT

13632391455liuyisysu@126.com

Jiang nan, doctor

CONTACT

13725407606jiangnanshen@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

May 26, 2015

First Posted

September 17, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

CN(1)