Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and IMA in Laparoscopic Cholecystectomy Surgery

NCT04926480 | Completed

• 1 other identifier: 2011-KAEK-25 2019 /12-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery In this study, our aim is to compare the effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in laparoscopic Cholecystectomy Surgery using Sevoflurane as an anesthetic gas routinely.

Conditions

Laparoscopic Cholecystectomy

Keywords

Low Flow; High Flow; tiyol-disülfid homeostasis; Modified Albumin

Outcome Measures

Primary Outcomes (2)

• Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide Homeostasis and Ischemia Modified Albumin in Laparoscopic Cholecystectomy Surgery

  In order to determine thiol / disulphid homeostasis and IMA serum level, 5 ml blood samples were taken 3 times from each patient (T0: 5 minutes before induction of anesthesia, T1: 5 minutes after abdominal gas is completely evacuated, T2: 24 hours postoperatively). Serum disulfide/thiol homeostasis measurements were determined by the automated spectrophotometric method described by Erel and Neşelioğlu.Thiol/disuphide hemostasis parameters were studied with the same serum samples in the same session. Ischemia modified albumen Bar-Or et al. The study was carried out using the spectrophotometric method suggested by The IMA is specified as the absorption unit (AUC).

  24 hours after operation

• Comparison of the Effects of Low Flow and High Flow Anesthesia on Thiol-Disulfide

  During the operation, heart rate beats/min were recorded on the monitor at the 5th, 10th, 15th, 30th, 45th, 60th, 90th, 120th, 150th, 180th and 210th minutes after intubation and at the end of extubation.

  during peroperative period

Study Arms (2)

low flow Anesthesia group

EXPERIMENTAL

Antioxidant parameters are measured in the low flow anesthesia group.

Procedure: low and high flow Anesthesia

high flow Anesthesia gruop

ACTIVE COMPARATOR

Antioxidant parameters are measured in the high flow anesthesia group.

Procedure: low and high flow Anesthesia

Interventions

low and high flow Anesthesia PROCEDURE

comparison of hemodynamic changes in low and high flow anesthesia groups

Also known as: Cholecystectomy Surgery

high flow Anesthesia gruop; low flow Anesthesia group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• Aged 18-70 years
• elective laparoscopic cholecystectomy surgery
• general anesthesia

You may not qualify if:

• Morbidly obese patients
• alcohol or drug addiction
• chronic obstructive pulmonary disease
• coronary artery disease
• congestive heart failure
• significant anemia
• liver or kidney disease
• allergy to propofol or halogenated drugs
• respiratory system pathology, hypotension
• hypovolemia and patients with a systemic disease
• patients using drugs that may affect the oxidation system
• patients who are converted to open surgery intraoperatively and develop complications

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (2)

Bursa yüksek ihtisas training and research hospital

Bursa, 16000, Turkey (Türkiye)

Location

Bursa yüksek ihtisas

Bursa, 16000, Turkey (Türkiye)

Location

Study Officials

• umran karaca, 3

  Assistant researcher

  STUDY DIRECTOR

• asıye demirel, 4

  Assistant researcher

  PRINCIPAL INVESTIGATOR

• mehmet gamlı, 5

  Assistant researcher

  PRINCIPAL INVESTIGATOR

• yasemin ustundag, 6

  Assistant researcher

  PRINCIPAL INVESTIGATOR

• ozcan erel, 7

  Assistant researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: low flow high flow
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist MD

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: June 15, 2021
• Study Start: January 10, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)