NCT03650283

Brief Summary

Determine the relation between PRST (pressure, rate, sweating, tears) score, skin conductance (SC) and Bispectral index (BIS) values during anesthesia

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

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

August 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

August 22, 2018

Last Update Submit

February 8, 2019

Conditions

Awakeness, Pain

Outcome Measures

Primary Outcomes (1)

  • Correlation between NFSC, PRST and BIS

    Correlation between NFSC-PRST and, BIS-PRST will be assessed.

    anesthesia induction (while giving induction agent to the patient), surgical incision (when the surgeon makes the first incision), extubation (when LMA is removed)

Interventions

monitoringOTHER

The bispectral index (BIS) and skin conductance (SC) monitors will be connected when patient will be positioned on the operating table. A BIS value greater than 60 will be considered an indicator of light anaesthesia. The SC monitoring will be achieved using the MEDSTORM AS 2005 monitor. Number of fluctuations in mean skin conductance (NFSC) of \>0.1 s-1 in a period of 15 s might be counted as a significant change and indicates an increase in the sympathetic outflow. General anaesthesia will be performed and laryngeal mask will be inserted. Blood pressure, heart rate, BIS, SC, and PRST (pressure, rate, sweating, tears) score will be recorded.

Eligibility Criteria

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

You may qualify if:

  • Minor elective surgery
  • General anaesthesia

You may not qualify if:

  • autonomic neuropathy
  • presence of a pacemaker
  • medication with anticholinergic drugs
  • use of ketamine, clonidine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Bahar SAKIZCI UYAR

CONTACT

5057000240drsakizciuyar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 28, 2018

Study Start

March 4, 2019

Primary Completion

April 30, 2019

Study Completion

May 31, 2019

Last Updated

February 11, 2019

Record last verified: 2019-02