NCT03563833

Brief Summary

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

May 20, 2018

Last Update Submit

June 19, 2018

Conditions

Oxidative Stress

Keywords

Minimal Flow AnesthesiaThiol/disulfide balanceTissue oxygen saturationhypotensive anesthesia

Outcome Measures

Primary Outcomes (1)

  • Thiol Disulfide Balance

    Change of Oxidative Stress Marker

    For two groups; First blood sample will be taken 30 min before the start of surgery, second blood sample will be taken at the 60th min of the surgery

Secondary Outcomes (1)

  • StO2

    For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery

Study Arms (2)

Minimal Flow Anesthesia

OTHER

Minimal Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5). In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg. Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.

Other: Minimal Flow Anesthesia

High Flow Anesthesia

OTHER

High Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5) In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg. Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.

Other: High Flow Anesthesia

Interventions

Minimal Flow AnesthesiaOTHER

Minimal Flow Anesthesia with 0,4 L min-1

Minimal Flow Anesthesia
High Flow AnesthesiaOTHER

High Flow Anesthesia with 2 L min-1

High Flow Anesthesia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA (American Society of Anesthesiologists) I tympanoplasty operations with hypotensive anesthesia,
  • ASA (American Society of Anesthesiologists) II tympanoplasty operations with hypotensive anesthesia,

You may not qualify if:

  • operations in less than one hour
  • uncontrolled hypertension
  • DM (Diabetes Mellitus)
  • cerebrovascular disease
  • coagulopathy
  • morbid obesity ((BMI ≥ 35)
  • renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University Training and Research Hospital

Rize, 53200, Turkey (Türkiye)

RECRUITING

Study Officials

  • Şule Batçık, Asst. Prof.

    Recep Tayyip Erdoğan University Medical School Department of Anesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Şule Batçık, Asst. Prof.

CONTACT

+904642130491drsulebatcik@gmail.com

Leyla Kazancıoğlu, Asst. Prof.

CONTACT

+904642130491leylahotaman@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 20, 2018

First Posted

June 20, 2018

Study Start

May 4, 2018

Primary Completion

October 31, 2018

Study Completion

November 30, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)