NCT03515876

Brief Summary

To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

April 23, 2018

Last Update Submit

April 5, 2019

Conditions

AnesthesiaEEG Power Spectra

Outcome Measures

Primary Outcomes (1)

  • EEG power spectra

    EEG power spectra monitored no-invasively by Narcotrend

    From prior to anesthesia to 10 min after anesthesia.

Secondary Outcomes (3)

  • Blood pressure

    From prior to anesthesia to 10 min after anesthesia.

  • Respiration

    From prior to anesthesia to 10 min after anesthesia.

  • Heart rates

    From prior to anesthesia to 10 min after anesthesia.

Study Arms (3)

Control

Patients will receive intravenous propofol infusion.

Dexmedetomidine 0.5 microgram/kg group

Patients will receive dexmedetomidine 0.5 microgram/kg and then intravenous propofol infusion.

Dexmedetomidine 1 microgram/kg group

Patients will receive dexmedetomidine 1 microgram/kg and then intravenous propofol infusion.

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients undergoing hysteroscopic examination and surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients for hysteroscopic examination and surgery under general anesthesia.

You may qualify if:

  • American Society of Anesthesiologists Physical status I to II grade.
  • body mass index 18 to 25 kg/m2
  • no vision or hearing impairment
  • will receive general anesthesia

You may not qualify if:

  • with psychological or mental diseases
  • with neurological diseases
  • treating with steroids or with alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Central Study Contacts

Zhi Wang, MD

CONTACT

13622740039wwzz1898@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 4, 2018

Study Start

April 19, 2018

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

CN(1)