Comparison of Two Anaesthetics on Brain During Brain Tumour Surgery

NCT02229201 | Completed Phase 1 DMC

• 1 other identifier: UMCL-NKG-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Anaesthesia and surgical stress during craniotomy can lead to brain damage and activation of inflammatory response. Consequently inflammatory cytokines (IL6, IL8, IL10) are released. Cell mediated immune balance can increase postoperative complications (infections, wound healing, multiple organ dysfunction). Many studies have shown that volatile anaesthetics reduce systemic and local inflammatory response during major surgery, but animal studies have shown that volatile anaesthetics can induce neuroinflammation (IL6, NF-κB) that leads to decline of cognitive function in rodent and possible human. Our aim was to investigate how anaesthetic technique for craniotomy influences the release of inflammatory cytokines. Our hypothesis was that when optimal neuroprotective strategies are followed during surgery intravenous anaesthesia attenuates inflammatory response comparing to inhalational anaesthesia. The investigators included 40 patients anaesthetised with remifentanil based anaesthesia with sevoflurane (S group) or propofol (P group). Plasma levels of IL6, IL8, IL10 were measured during preoperative, perioperative and postoperative periods of both groups of patients. The investigators also noted emergence parameters, postoperative (pain, shivering, vomiting) and neurological complications after surgery.

Conditions

Inflammation

Keywords

propofol; sevoflurane; Interleukin 6; Interleukin 10

Outcome Measures

Primary Outcomes (1)

• Interleukin 10 plasma concentrations

  The interleukin 10 plasma concentrations during craniotomy (preoperative, perioperative and postoperative periods)

  Within 48 hours (1. Before surgery and anaesthesia 2. During surgery, 3. At the end of surgery 4.First postoperative day 5.Second postoperative day)

Secondary Outcomes (9)

• Hospital stay

  within the first 15 days after surgery

• Pulmonary complications

  within the first 15 days after surgery

• Cardiovascular complications

  within the first 15 days after surgery

• Neurological complications

  within the first 15 days after surgery

• Reoperation

  within the first 15 days after surgery

Other Outcomes (10)

• Consumption of Propofol (mg)

  within first 12 hours from the time before the surgery until the end of surgery

• Consumption Remifentanil (mg)

  within first 12 hours from the time before the surgery until the end of surgery

• Consumption of efedrin (mg)

  within first 12 hours from the time before the surgery until the end of surgery

Study Arms (2)

Propofol

EXPERIMENTAL

intravenous anaesthetic

Drug: Propofol

Sevoflurane

ACTIVE COMPARATOR

volatile anaesthetic

Drug: Sevoflurane

Interventions

Propofol DRUG

4-6 mg/kg/h during anaesthesia

Also known as: Propoven 1%

Propofol

Sevoflurane DRUG

0.8 MAC

Also known as: Sevorane

Sevoflurane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 years
• American Society of Anaesthesiologists (ASA) physical status I-III
• Scheduled for brain tumour surgery
• Glasgow Coma Score 15
• Cooperative

You may not qualify if:

• No written informed consent
• Eendocrine systematic disease
• Ddrugs that alter endocrine metabolism
• History of drug hypersensitivity
• Drug addiction
• Perioperative blood derivatives.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• Blum FE, Zuo Z. Volatile anesthetics-induced neuroinflammatory and anti-inflammatory responses. Med Gas Res. 2013 Aug 1;3(1):16. doi: 10.1186/2045-9912-3-16.

  PMID: 23915963 BACKGROUND

• El Beheiry H. Protecting the brain during neurosurgical procedures: strategies that can work. Curr Opin Anaesthesiol. 2012 Oct;25(5):548-55. doi: 10.1097/ACO.0b013e3283579622.

  PMID: 22895122 BACKGROUND

• Markovic-Bozic J, Karpe B, Potocnik I, Jerin A, Vranic A, Novak-Jankovic V. Effect of propofol and sevoflurane on the inflammatory response of patients undergoing craniotomy. BMC Anesthesiol. 2016 Mar 22;16:18. doi: 10.1186/s12871-016-0182-5.

  PMID: 27001425 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Jasmina Markovic Bozic, MD, MSC

  CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan

  PRINCIPAL INVESTIGATOR

• Blaz Karpe, PHD

  Faculty of Natural Science and Engineering, University of Ljubljana

  PRINCIPAL INVESTIGATOR

• Iztok Potocnik, MD, MSC

  CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan

  PRINCIPAL INVESTIGATOR

• Ales Jerin, PHD

  CLINICAL INSTITUTE OF CLINICAL CHEMISTRY AND BIOCHEMISTRY, University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

• Andrej Vranič, MD, PHD

  CD of Neurosurgery, University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

• Vesna Novak Jankovic, PROF, PHD

  CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSC

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: September 1, 2014
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 1, 2014

Record last verified: 2014-08

Locations

SL (1)