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Postoperative ComplicationsNCT03187717

Total Intravenous Anesthesia and Inhalation Anesthesia

An observational study of Postoperative Complications, run by Aydin Adnan Menderes University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Complications
Type of treatment
Injection or infusion
How many people
583 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 1 Feb 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: The Comparison of Total Intravenous Anesthesia and Inhalation Anesthesia Procedures Used in Oral and Maxillofacial Surgeries in View of Postoperative Complications and the Recovery Period

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.

Read the detailed description

Totally American Society of Anesthesiologists (ASA) I-II, 18-60 ages, 583 patients who had had oral and maxillofacial operations for 30 minutes and over with TIVA and IA methods between 1st Jan, 2016 and 1st Jan, 2017. The ones who had insufficient data in their files and who were conscious / superficial sedation patients were excluded from the study. The patients were allocated to two groups as TIVA and IA. The total intravenous anesthesia group was named "Group TIVA" , and the volatile anesthesia group was named "Group IA".

All the patients were opened vascular access after being taken into the operation room and were given anesthesia induction with 1 µg/kg fentanyl, 2 mg/kg propofol and 0,8 mg/kg rocuronium. The patients in Group IA were given 1-2% volume sevoflurane in 50% oxygen and 50% nitrous oxide during maintenance of anesthesia, while the patients in group TIVA were applied 4-10 mg/kg/h propofol and 0.05-0.1 µg/kg fentanyl IV infusion with 50% oxygen and 50% air. While being woken up, each patient was given 0.3 mg/kg tenoxicam for analgesia and 0.2 mg/kg metoclopramide for nausea-vomiting prophylaxis in a routine way. Each patient was taken into recovery room after extubation and pulse rate, non-invasive blood pressure (NIBP) and oxygen saturation monitorization were done. Postoperative complication and vital finding tracks of each patient were done as usual and were recorded.

Keywords
Postoperative pain, Recovery period, Total intravenous anesthesia, Inhalation anesthesia
Medical subject headings
Postoperative Complications, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03187717
Study groupRoleWhat they receive
TIVA (Total intravenous anesthesia)Group TIVA; patients who used intravenous anesthesia procedure
IA (Inhalation anesthesia)Group IA; patients who used inhalation anesthesia procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain

    Visual Analog Scale (VAS)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2017
  2. Study start1 Jan 2016
  3. Primary completion1 Jan 2017
  4. Study completion1 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03187717
Sponsor's protocol ID
OzlemKocaturk
Status last verified
Jun 2017
First submitted
22 May 2017
Last updated
15 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20934965

  • 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.

    PubMed 25500679

  • 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.

    PubMed 8623947

  • 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.

    PubMed 11064611

  • 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.

    PubMed 23493938

  • 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.

    PubMed 7840401

  • 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.

    PubMed 10866915

  • 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.

    PubMed 10023274

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Complications, run by Aydin Adnan Menderes University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03187717, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.

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