NCT03187717

Brief Summary

The aim of us is to define the incidence of postoperative complications and recovery time in view of two anesthesia procedures. During the period between 01.01.2016 and 01.01.2017, totally 583 patients were included in the study, who had oral and maxillofacial surgeries. Anesthesia types were determined as total intravenous anesthesia (TIVA) and inhalation anesthesia (IA). Postoperative complications and recovery period were determined as tachycardia, bradycardia, hypertension, hypotension, recovery time, additional analgesia, nausea-vomiting. Both anesthesia procedures were compared in terms of these postoperative complications and recovery time.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
583

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

May 22, 2017

Last Update Submit

June 13, 2017

Conditions

Postoperative Complications

Keywords

Postoperative painRecovery periodTotal intravenous anesthesiaInhalation anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Visual Analog Scale (VAS)

    1 year

Study Arms (2)

TIVA (Total intravenous anesthesia)

Group TIVA; patients who used intravenous anesthesia procedure

IA (Inhalation anesthesia)

Group IA; patients who used inhalation anesthesia procedure

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

ASA I-II, 18-60 ages patients who had had maxillofacial surgery for 30 minutes and over with TIVA and IA prosedures between 1st Jan, 2016 and 1st Jan, 2017 were our study population.

You may qualify if:

  • Totally American Society of Anesthesiologists (ASA) I-II, 18-60 ages patients who had had oral and maxillofacial operations for 30 minutes and over with TIVA and IA procedures between 1st Jan, 2016 and 1st Jan, 2017.

You may not qualify if:

  • The ones who had insufficient data in their files and who were conscious/superficial sedation patients were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Gecaj-Gashi A, Hashimi M, Sada F, Baftiu N, Salihu S, Terziqi H, Bruqi B. Propofol vs isoflurane anesthesia-incidence of PONV in patients at maxillofacial surgery. Adv Med Sci. 2010;55(2):308-12. doi: 10.2478/v10039-010-0033-4.

    PMID: 20934965BACKGROUND

  • Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.

    PMID: 25500679BACKGROUND

  • Jellish WS, Lien CA, Fontenot HJ, Hall R. The comparative effects of sevoflurane versus propofol in the induction and maintenance of anesthesia in adult patients. Anesth Analg. 1996 Mar;82(3):479-85. doi: 10.1097/00000539-199603000-00009.

    PMID: 8623947BACKGROUND

  • Watson KR, Shah MV. Clinical comparison of 'single agent' anaesthesia with sevoflurane versus target controlled infusion of propofol. Br J Anaesth. 2000 Oct;85(4):541-6. doi: 10.1093/bja/85.4.541.

    PMID: 11064611BACKGROUND

  • Bharti N, Chari P, Kumar P. Effect of sevoflurane versus propofol-based anesthesia on the hemodynamic response and recovery characteristics in patients undergoing microlaryngeal surgery. Saudi J Anaesth. 2012 Oct-Dec;6(4):380-4. doi: 10.4103/1658-354X.105876.

    PMID: 23493938BACKGROUND

  • Adams HA, Schmitz CS, Baltes-Gotz B. [Endocrine stress reaction, hemodynamics and recovery in total intravenous and inhalation anesthesia. Propofol versus isoflurane]. Anaesthesist. 1994 Nov;43(11):730-7. doi: 10.1007/s001010050115. German.

    PMID: 7840401BACKGROUND

  • Joo HS, Perks WJ. Sevoflurane versus propofol for anesthetic induction: a meta-analysis. Anesth Analg. 2000 Jul;91(1):213-9. doi: 10.1097/00000539-200007000-00040.

    PMID: 10866915BACKGROUND

  • Dashfield AK, Birt DJ, Thurlow J, Kestin IG, Langton JA. Recovery characteristics using single-breath 8% sevoflurane or propofol for induction of anaesthesia in day-case arthroscopy patients. Anaesthesia. 1998 Nov;53(11):1062-6. doi: 10.1046/j.1365-2044.1998.00571.x.

    PMID: 10023274BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsPain, Postoperative

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ozlem Kocaturk, MD

    Faculty of Dentistry, Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, Assistant Professor

Study Record Dates

First Submitted

May 22, 2017

First Posted

June 15, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share