- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03187717
Total Intravenous Anesthesia and Inhalation Anesthesia
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The ones who had insufficient data in their files and who were conscious/superficial sedation patients were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain
Time Frame: 1 year
|
Visual Analog Scale (VAS)
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ozlem Kocaturk, MD, Faculty of Dentistry, Adnan Menderes University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OzlemKocaturk
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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