Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery

NCT02217319 | Completed

• 1 other identifier: HSK005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

It has been shown that the use of volatile anaesthetics, that are usually used to perform a general anesthesia, have cardioprotective properties. This has been shown in animal studies and in patients that underwent cardiac surgery. The aim of our study is to examine if Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.

Conditions

High Sensitive Troponin T Release

Keywords

Volatile Anesthetic; Cardioprotection; Lung surgery; non cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Troponin T

  assessing a change in high sensitive Troponin T (5th generation) Level before and at six time points after surgery (right after surgery, every 8 hours up to 40 hours after surgery)

  change of Troponin T levels preoperative and postoperative up to 40 hours after surgery

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning.

Drug: Sevoflurane

TIVA

PLACEBO COMPARATOR

Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.

Drug: TIVA

Interventions

Sevoflurane DRUG

Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.

Sevoflurane

TIVA DRUG

Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).

Also known as: Placebo, Controll

TIVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lung surgery
• ASA (American Society of Anesthesiologists) physical status 1-3

You may not qualify if:

• Disposition for malignant hyperthermia
• Medication with ß-blocking drugs
• Use of clonidin

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (1)

Dr Horst Schmidt Klinik

Wiesbaden, 65199, Germany

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 15, 2014
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

DE (1)