Study of Anaesthesia Costs and Recovery Profiles

NCT ID: NCT02920749

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-10-31

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.

Detailed Description

Sevoflurane and propofol are two basic drugs in the maintenance of anaesthesia. In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia for otorhinolaryngeal surgery. Patients were equally divided into four anaesthetic subgroups. In groups A and C anaesthesia was based on sevoflurane or propofol, respectively, without bispectral index (BIS) and train-of-for monitor (TOF) monitoring. In groups B and D anaesthesia was based on sevoflurane or propofol, respectively, with BIS and TOF monitoring. Drug consumption, recovery profiles and anaesthesia costs were analysed.

ECG, main arterial pressure (MAP), heart rate, oxygen saturation of peripheral haemoglobin (SpO2), pressure of end-tidal carbon dioxide was monitored continuously and registered at 5 min intervals during anaesthesia. Each group received propofol for anaesthesia induction. In group A and B anaesthesia was maintained with sevoflurane, in groups C and D with propofol. In groups B and D the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) were monitored too. BIS and TOF values were recorded at 5 min intervals.

Conditions

Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sevoflurane group A

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

Group Type: OTHER

Sevoflurane group A

Intervention Type: 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.

Sevoflurane group B

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.

Group Type: OTHER

Sevoflurane group B

Intervention Type: 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.

Propofol group C

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

Group Type: OTHER

Propofol group C

Intervention Type: DRUG

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

Propofol group D

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

Group Type: OTHER

Propofol group D

Intervention Type: 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.

Interventions

Sevoflurane group A

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.

Intervention Type: DRUG

Sevoflurane group B

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.

Intervention Type: DRUG

Propofol group C

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

Intervention Type: DRUG

Propofol group D

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.

Intervention Type: DRUG

Other Intervention Names

Sevorane anaesthesia; Sevorane anaesthesia with BIS and TOF monitoring; Propofol anaesthesia; Propofol anaesthesia with BIS and TOF monitoring

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Timea Bocskai

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Csaba Loibl, MD

Role: STUDY_CHAIR

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

Zoltan Vamos, MD, PhD

Role: STUDY_CHAIR

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

Gabor Woth, MD, PhD

Role: STUDY_CHAIR

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

Lajos Bogar, MD, PhD, DSc

Role: STUDY_DIRECTOR

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

Laszlo Lujber, MD, PhD

Role: STUDY_DIRECTOR

Department of Otorhinolaryngology, University of Pecs, Hungary

Locations

Tímea Bocskai

Pécs, Ifjusag Street 13., Hungary

Countries

Hungary

References

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.

Reference Type: DERIVED

PMID: 30055562 (View on PubMed)

Other Identifiers

316-2336/KK15

Identifier Type: -

Identifier Source: org_study_id