Total Intravenous Anesthesia With Remifentanil-propofol Admixture

NCT ID: NCT04394897

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-12

Study Completion Date

2014-04-12

Brief Summary

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Background: Application of total intravenous anesthesia (TIVA) may be considered as unpractical when compared with inhalational anesthesia. Although it is mostly not recommended, mixing intravenous agents seems to be popular in clinical practice. The aim of the study was to investigate the possible clinical drawbacks of using remifentanil-propofol admixture (MIXTIVA) for TIVA.

Detailed Description

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ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each) to have TIVA either with remifentanil and propofol infusions separately (control group, Group I) or with MIXTIVA infusion that had remifentanil/propofol proportion 2/1000 or 3/1000 (remifentanil concentration 20 µg/ml or 30 µg/ml in propofol 1%, Group II or Group III respectively).

This technique may be considered as a practical implementation for busy ambulatory surgery centers performing general anesthesia, but delayed recovery may be predicted with longer duration of surgery and anesthesia.

Conditions

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Total Intravenous Anesthesia Propofol Remifentanil Bispectral Index Monitoring

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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TIVA

TIVA either with remifentanil and propofol infusions separately

No interventions assigned to this group

MIXTIVA 2/1000

MIXTIVA infusion that had remifentanil/propofol proportion 2/1000

Remifentanil-Propofol admixture

Intervention Type COMBINATION_PRODUCT

MIXTIVA 3/1000

MIXTIVA infusion that had remifentanil/propofol proportion 3/1000

Remifentanil-Propofol admixture

Intervention Type COMBINATION_PRODUCT

Interventions

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Remifentanil-Propofol admixture

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status I patients American Society of Anesthesiologists (ASA) physical status II patients

Exclusion Criteria

American Society of Anesthesiologists (ASA) physical status III patients or above patients A body mass index \>35 kg/m2 Pregnant patients Breast-feeding Menstruating women Patients who were not euthyroid Uncontrolled hypertension Hepatic, renal or cardiac insufficiency Alcohol, opioid or drug abuse Allergy or contraindication to any of the study drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Anderson BJ, Bagshaw O. Practicalities of Total Intravenous Anesthesia and Target-controlled Infusion in Children. Anesthesiology. 2019 Jul;131(1):164-185. doi: 10.1097/ALN.0000000000002657.

Reference Type BACKGROUND
PMID: 30920966 (View on PubMed)

Errando CL, Sigl JC, Robles M, Calabuig E, Garcia J, Arocas F, Higueras R, Del Rosario E, Lopez D, Peiro CM, Soriano JL, Chaves S, Gil F, Garcia-Aguado R. Awareness with recall during general anaesthesia: a prospective observational evaluation of 4001 patients. Br J Anaesth. 2008 Aug;101(2):178-85. doi: 10.1093/bja/aen144. Epub 2008 May 30.

Reference Type BACKGROUND
PMID: 18515816 (View on PubMed)

Roberts FL, Dixon J, Lewis GT, Tackley RM, Prys-Roberts C. Induction and maintenance of propofol anaesthesia. A manual infusion scheme. Anaesthesia. 1988 Mar;43 Suppl:14-7. doi: 10.1111/j.1365-2044.1988.tb09061.x.

Reference Type BACKGROUND
PMID: 3259089 (View on PubMed)

Lamperti M. Adult procedural sedation: an update. Curr Opin Anaesthesiol. 2015 Dec;28(6):662-7. doi: 10.1097/ACO.0000000000000244.

Reference Type BACKGROUND
PMID: 26356290 (View on PubMed)

Weatherall A, Venclovas R. Experience with a propofol-ketamine mixture for sedation during pediatric orthopedic surgery. Paediatr Anaesth. 2010 Nov;20(11):1009-16. doi: 10.1111/j.1460-9592.2010.03420.x.

Reference Type BACKGROUND
PMID: 20964766 (View on PubMed)

Bakan M, Umutoglu T, Topuz U, Guler EY, Uysal H, Ozturk E. Prospective evaluation of remifentanil-propofol mixture for total intravenous anesthesia: A randomized controlled study. Exp Ther Med. 2021 Nov;22(5):1198. doi: 10.3892/etm.2021.10632. Epub 2021 Aug 23.

Reference Type DERIVED
PMID: 34584543 (View on PubMed)

Other Identifiers

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Bezmialem VU

Identifier Type: -

Identifier Source: org_study_id

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