Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

TEAS to Reduce Propofol Consumption During General Anesthesia (TOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02314650
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Zhihong LU, Fourth Military Medical University

Brief Summary:
The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery.

Condition or disease Intervention/treatment Phase
Anesthesia Other: acupoint stimulation Other: non-acupoint stimulation Other: electrodes attached Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcutaneous Electrical Acupoint Stimulation on Propofol Consumption During General Anesthesia
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Transcutaneous acupoint stimulation
Electrical stimulation was given through electrodes attached to skin at Ximen and Shenmen acupoint during anesthesia
Other: acupoint stimulation
stimulation was given at acupoints

Other: electrodes attached
electrode were attached to skin

Placebo Comparator: Non-acupoint stimulation
Electrical stimulation was given through electrodes attached to skin at shoulder (non-acupoint) during anesthesia
Other: non-acupoint stimulation
stimulation was given at non-acupoints

Other: electrodes attached
electrode were attached to skin

Sham Comparator: Control
patients were with electrodes attached but no stimulation was given
Other: electrodes attached
electrode were attached to skin




Primary Outcome Measures :
  1. propofol consumption [ Time Frame: from induction to the end of surgery,at an average of 1 hour ]

Secondary Outcome Measures :
  1. time to awake [ Time Frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes ]
  2. time to extubation [ Time Frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes ]
  3. effect site concentration of propofol at awake [ Time Frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes ]
  4. highest sedation score during stay at postanesthesia care unit [ Time Frame: from leaving the operating room to leaving the PACU,at an average of 30min ]
  5. level of plasma melatonin concentration at 30min after surgery [ Time Frame: 30min after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing minor surgeries including laparoscopic surgery and breast surgery under general anesthesia
  • Patients with written informed consent

Exclusion Criteria:

  • Patients with difficulty to communicate,including psychiatric disorder and Alzheimer's disease
  • Patients with drug abuse
  • Patients with disease of central nervous system
  • Patients with renal or hepatic dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314650


Locations
Layout table for location information
China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Layout table for investigator information
Principal Investigator: Zhihong LU, PhD Fourth Military Medical University

Publications of Results:
Layout table for additonal information
Responsible Party: Zhihong LU, Dr, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02314650     History of Changes
Other Study ID Numbers: XJH-A-2014-6-25-01
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General