NCT04394897

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

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

March 12, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2014

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

April 9, 2020

Last Update Submit

May 14, 2020

Conditions

Total Intravenous AnesthesiaPropofolRemifentanilBispectral Index Monitoring

Outcome Measures

Primary Outcomes (3)

  • Heart Rate Changes

    Bradycardia: heart rate \<45 beat per / min

    During the application of TIVA

  • Blood Pressure Changes

    Hypotension (MAP \<60 mmHg), Hypertension( systolic arterial pressure \>150 mmHg)

    During the application of TIVA

  • Bispectral Index (BIS) Changes

    BIS levels \>60

    During the application of TIVA

Study Arms (3)

TIVA

TIVA either with remifentanil and propofol infusions separately

MIXTIVA 2/1000

MIXTIVA infusion that had remifentanil/propofol proportion 2/1000

Combination Product: Remifentanil-Propofol admixture

MIXTIVA 3/1000

MIXTIVA infusion that had remifentanil/propofol proportion 3/1000

Combination Product: Remifentanil-Propofol admixture

Interventions

Remifentanil-Propofol admixtureCOMBINATION_PRODUCT
MIXTIVA 2/1000MIXTIVA 3/1000

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 30920966BACKGROUND

  • 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.

    PMID: 18515816BACKGROUND

  • 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.

    PMID: 3259089BACKGROUND

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

    PMID: 26356290BACKGROUND

  • 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.

    PMID: 20964766BACKGROUND

  • 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.

    PMID: 34584543DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

May 20, 2020

Study Start

March 12, 2013

Primary Completion

April 12, 2014

Study Completion

April 12, 2014

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share