NCT02323958

Brief Summary

This study is to observe whether transcutaneous electrical stimulation at specific acupoints could improve the quality of emergence in patients undergoing robotic laparoscopic gynecologic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

December 8, 2014

Last Update Submit

July 25, 2017

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Time to awake

    time to open eyes to verbal command

    from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour

Secondary Outcomes (9)

  • Richmond Score

    from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour

  • Time to extubation

    from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour

  • QoR-15

    from end of inhaling sevoflurane to 24h after surgery,an anticipated average of 24 hour

  • residual sedation

    from arriving at PACU to departing from PACU,an anticipated average of 30min

  • PONV

    from arriving at PACU to departing from PACU,an anticipated average of 30min

  • +4 more secondary outcomes

Study Arms (3)

Acupoint stimulation

EXPERIMENTAL

Electrical stimulation is given through electrodes attached to acupoints

Other: acupoint stimulationOther: electrode attachedDevice: electrical stimulation

Non-acupoint stimulation

PLACEBO COMPARATOR

Electrical stimulation is given through electrodes attached to non-acupoints

Other: non-acupoint stimulationOther: electrode attachedDevice: electrical stimulation

Control stimulation

SHAM COMPARATOR

Electrode attached but no stimulation is given

Other: electrode attached

Interventions

acupoint stimulationOTHER

stimulation is given at acupoints

Acupoint stimulation
non-acupoint stimulationOTHER

stimulation is given at acupoints

Non-acupoint stimulation
electrode attachedOTHER

electrodes are attached to skin

Also known as: electrode
Acupoint stimulationControl stimulationNon-acupoint stimulation
electrical stimulationDEVICE

electrical stimulation is given through electrodes attached to th skin

Acupoint stimulationNon-acupoint stimulation

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for robotic laparoscopic gynecologic surgery under general anesthesia
  • Patients with written informed consent

You may not qualify if:

  • Patients with difficulty in communication
  • Patients with disease of central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

  • Schramm P, Treiber AH, Berres M, Pestel G, Engelhard K, Werner C, Closhen D. Time course of cerebrovascular autoregulation during extreme Trendelenburg position for robotic-assisted prostatic surgery. Anaesthesia. 2014 Jan;69(1):58-63. doi: 10.1111/anae.12477. Epub 2013 Nov 20.

    PMID: 24256501RESULT

  • Pandey R, Garg R, Darlong V, Punj J, Chandralekha, Kumar A. Unpredicted neurological complications after robotic laparoscopic radical cystectomy and ileal conduit formation in steep trendelenburg position: two case reports. Acta Anaesthesiol Belg. 2010;61(3):163-6.

    PMID: 21268573RESULT

MeSH Terms

Interventions

ElectrodesElectric Stimulation

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and SuppliesPhysical StimulationInvestigative Techniques

Study Officials

  • Hailong Dong, PhD

    Air Force Military Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 24, 2014

Study Start

December 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

CN(1)