NCT06843031

Brief Summary

The relationship between perfusion index and postanesthetic shivering has been investigated in limited studies. Previous studies have investigated the relationship between postanesthetic shivering after total intravenous anesthesia and perfusion index. The relationship between inhalational anesthesia and postoperative shivering has been investigated, but the role of perfusion index on shivering has also been evaluated in limited studies. Therefore, investigators aimed to investigate whether perianesthetic changes in perfusion index in patients under general anesthesia (inhalation anesthesia and total intravenous anesthesia) correlate with the incidence of postanesthetic shivering and whether they are useful in predicting postanesthetic shivering.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

June 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 14, 2025

Last Update Submit

February 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • peripheral perfusion index

    From enrollment until the 10th minute after extubation

Study Arms (2)

Arm inhalation anesthesia

Evaluation of peripheral perfusion index during routine monitoring in patients undergoing surgery by gynecologic oncology under desflurane inhalation anesthesia.

Arm total intravenous anesthesia

Evaluation of peripheral perfusion index during routine monitoring in patients undergoing surgery by gynecologic oncology under total intravenous anesthesia.

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study was prepared as a prospective study and submitted to the approval of the Health Sciences University Kanuni Sultan Süleyman E.A.H. Ethics Committee Committee. The study includes adult female patients over the age of 20 who underwent elective gynecological oncology operations under general anesthesia.

You may qualify if:

  • over the age of 20,
  • in the ASA I-II, III
  • who were planned to undergo elective surgery

You may not qualify if:

  • under the age of 20,
  • those who did not consent,
  • those with mental and/or psychiatric disorders,
  • in the ASA IV
  • History of allergy to drugs to be used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34303, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Anesthesiology and Reanimation, Principal Investigator

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 24, 2025

Study Start

June 15, 2019

Primary Completion

June 15, 2020

Study Completion

June 15, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations