Total Intravenous Anesthesia With Remifentanil-propofol Admixture

Propofol Clinical Trial

Official title:

Total Intravenous Anesthesia With Remifentanil-propofol Admixture Using Single-infusion Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394897
• Other study ID #: Bezmialem VU
• Status: Completed
• Start date: March 12, 2013
• Est. completion date: April 12, 2014

Study information

• Verified date: May 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 12, 2014
• Est. primary completion date: April 12, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bispectral Index Monitoring
• Propofol
• Remifentanil
• Total Intravenous Anesthesia

Intervention

Combination Product:
• Remifentanil-Propofol admixture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

References & Publications (5)

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. Review. — View Citation

Errando CL, Sigl JC, Robles M, Calabuig E, García J, Arocas F, Higueras R, Del Rosario E, López D, Peiró CM, Soriano JL, Chaves S, Gil F, García-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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Changes	Bradycardia: heart rate <45 beat per / min	During the application of TIVA
Primary	Blood Pressure Changes	Hypotension (MAP <60 mmHg), Hypertension( systolic arterial pressure >150 mmHg)	During the application of TIVA
Primary	Bispectral Index (BIS) Changes	BIS levels >60	During the application of TIVA