Study of Anaesthesia Costs and Recovery Profiles

NCT02920749 | Completed Results DMC

• 1 other identifier: 316-2336/KK15
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anesthesia for otorhinolaryngeal surgery.

Conditions

Anaesthesia

Keywords

anaesthesia; costs; recovery profiles

Outcome Measures

Primary Outcomes (1)

• Drug Consumption

  drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams

  at induction one dose and during anaesthesia mg/1 hour

Secondary Outcomes (1)

• Costs of Anaesthesia

  1 hour

Study Arms (4)

Sevoflurane group A

OTHER

Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.

Drug: Sevoflurane group A

Sevoflurane group B

OTHER

Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.

Drug: Sevoflurane group B

Propofol group C

OTHER

During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol).

Drug: Propofol group C

Propofol group D

OTHER

Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.

Drug: Propofol group D

Interventions

Sevoflurane group A DRUG

In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was adjusted for the same MAP range.

Also known as: Sevorane anaesthesia

Sevoflurane group A

Sevoflurane group B DRUG

In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.

Also known as: Sevorane anaesthesia with BIS and TOF monitoring

Sevoflurane group B

Propofol group C DRUG

In this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range.

Also known as: Propofol anaesthesia

Propofol group C

Propofol group D DRUG

In this group anaesthesia was maintained with propofol. Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.

Also known as: Propofol anaesthesia with BIS and TOF monitoring

Propofol group D

Eligibility Criteria

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

You may qualify if:

• ASA physical status grade I or II who were scheduled for elective otorhinolaryngological surgery.

You may not qualify if:

• Individuals with a history of bronchial asthma, chronic obstructive pulmonary disease, epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Tímea Bocskai

Pécs, Ifjusag Street 13., 7624, Hungary

Location

Related Publications (1)

• Bocskai T, Loibl C, Vamos Z, Woth G, Molnar T, Bogar L, Lujber L. Cost-effectiveness of anesthesia maintained with sevoflurane or propofol with and without additional monitoring: a prospective, randomized controlled trial. BMC Anesthesiol. 2018 Jul 28;18(1):100. doi: 10.1186/s12871-018-0563-z.

  PMID: 30055562 DERIVED

Limitations and Caveats

This study is restricted to anaesthesia of otorhinolaryngological surgery with controlled hypotension. Therefore, we cannot draw any conclusions related to other surgeries.

Results Point of Contact

• Title: Dr. Timea Bocskai
• Organization: Department of Anaesthesiology and Intensive Therapy, University of Pecs

bocskai.timea@pte.hu

36 72 507374

Study Officials

• Csaba Loibl, MD

  Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary

  STUDY CHAIR

• Zoltan Vamos, MD, PhD

  Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary

  STUDY CHAIR

• Gabor Woth, MD, PhD

  Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary

  STUDY CHAIR

• Lajos Bogar, MD, PhD, DSc

  Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary

  STUDY DIRECTOR

• Laszlo Lujber, MD, PhD

  Department of Otorhinolaryngology, University of Pecs, Hungary

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 6, 2018
• Results First Posted: December 6, 2016

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

HU (1)