Observation of Propofol Titration at Different Speeds

NCT04595591 | Completed

• 1 other identifier: 2020ZSLYEC-182
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol is one of the most widely used anesthetics for its fast onset and quick elimination. The conventional speed of its induction dose often causes severe hemodynamics fluctuations with hypotension and arrhythmia. The recommended dosage on the drug insert comes from group pharmacokinetic studies which does not apply to the specific situation of every patient, so the investigators emphasize individualized medication. The investigators have observed the titration of propofol in general anesthesia induction, and found that the dosage was less and the hemodynamics was becoming more stable. At the same time, the investigators found that the hemodynamics still has obvious fluctuations in the titration of the administration rate recommended in the instructions. The investigators intend to further compare the effects of propofol titration administration at different rates for hemodynamics and stress during the induction period of general anesthesia, and find a safer and more appropriate rate of administration.

Conditions

Anesthesia, General; Hemodynamics

Keywords

titration of propofol

Outcome Measures

Primary Outcomes (1)

• Mean blood pressure(MBP)

  Relative change of MBP(decreased more than 30%) in the three groups

  During the procedure of anesthesia induction

Secondary Outcomes (11)

• Stroke Volume (SV)

  During the procedure of anesthesia induction

• Cardiac Output (CO)

  During the procedure of anesthesia induction

• Systemic Vascular Resistance (SVR)

  During the procedure of anesthesia induction

• Catecholamine

  During the procedure of anesthesia induction

• Plasma concentration change curves

  During the procedure of anesthesia induction

Study Arms (3)

Group Ⅰ

ACTIVE COMPARATOR

titration dosing speeds of propofol at 2mg/kg/min

Drug: 2mg/kg/min

Group Ⅱ

ACTIVE COMPARATOR

titration dosing speeds of propofol at 1mg/kg/min

Drug: 1mg/kg/min

Group III

ACTIVE COMPARATOR

titration dosing speeds of propofol at 0.5mg/kg/min

Drug: 0.5mg/kg/min

Interventions

2mg/kg/min DRUG

titration dosing speeds of propofol at 2mg/kg/min

Also known as: Remifentanil 2ug/kg, Rocuronium 1.5mg/kg

Group Ⅰ

1mg/kg/min DRUG

titration dosing speeds of propofol at 1mg/kg/min

Also known as: Remifentanil 2ug/kg, Rocuronium 1.5mg/kg

Group Ⅱ

0.5mg/kg/min DRUG

titration dosing speeds of propofol at 0.5mg/kg/min

Also known as: Remifentanil 2ug/kg, Rocuronium 1.5mg/kg

Group III

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 Years old
• Elective surgery for general anesthesia through oral tracheal intubation and surgery is expected to last more than 2 hours
• The American Society of Anesthesiologists(ASA) grade is I or II, and the cardiac function is 1-2;
• Body mass index (BMI) 18-30 kg/m2;

You may not qualify if:

• Patients have severe heart, lung, liver, and kidney diseases (heart function grade\>3 / respiratory failure / liver failure / renal failure)
• Patients with arrhythmia: sinus bradycardia (ventricular rate \<60 beats/min), atrial fibrillation, atrial flutter, atrioventricular block, frequent ventricular premature, multi-source ventricular premature, ventricular premature R on T, Ventricular fibrillation and ventricular flutter.
• Patients who are expected to be difficult to intubate, hypoalbuminemia(albumin is less than 35g/L), hypertension and diabetes;
• Patients with a higher risk of reflux and aspiration, such as full stomach, gastrointestinal obstruction, gastroparesis, and pregnant women;
• Patients have schizophrenia, epilepsy, Parkinson's disease, intellectual disability, hearing impairment, abnormal EEG, etc.;
• Patients who take sedative and analgesic drugs for a long time;
• Patients who are allergic to propofol or its fat emulsion;
• Patients who are participating in other clinical trials, and who refuse to sign informed consent.

Sponsors & Collaborators

• SanQing Jin: lead

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (13)

• Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.

  PMID: 30027443 BACKGROUND

• de Wit F, van Vliet AL, de Wilde RB, Jansen JR, Vuyk J, Aarts LP, de Jonge E, Veelo DP, Geerts BF. The effect of propofol on haemodynamics: cardiac output, venous return, mean systemic filling pressure, and vascular resistances. Br J Anaesth. 2016 Jun;116(6):784-9. doi: 10.1093/bja/aew126.

  PMID: 27199311 BACKGROUND

• Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.

  PMID: 23835589 BACKGROUND

• Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.

  PMID: 28974066 BACKGROUND

• Blokland Y, Farquhar J, Lerou J, Mourisse J, Scheffer GJ, Geffen GJ, Spyrou L, Bruhn J. Decoding motor responses from the EEG during altered states of consciousness induced by propofol. J Neural Eng. 2016 Apr;13(2):026014. doi: 10.1088/1741-2560/13/2/026014. Epub 2016 Feb 9.

  PMID: 26859192 BACKGROUND

• Aho AJ, Kamata K, Jantti V, Kulkas A, Hagihira S, Huhtala H, Yli-Hankala A. Comparison of Bispectral Index and Entropy values with electroencephalogram during surgical anaesthesia with sevoflurane. Br J Anaesth. 2015 Aug;115(2):258-66. doi: 10.1093/bja/aev206. Epub 2015 Jul 1.

  PMID: 26137969 BACKGROUND

• Sepulveda P, Cortinez LI, Irani M, Egana JI, Contreras V, Sanchez Corzo A, Acosta I, Sitaram R. Differential frontal alpha oscillations and mechanisms underlying loss of consciousness: a comparison between slow and fast propofol infusion rates. Anaesthesia. 2020 Feb;75(2):196-201. doi: 10.1111/anae.14885. Epub 2019 Dec 1.

  PMID: 31788791 BACKGROUND

• Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.

  PMID: 26275092 BACKGROUND

• Fudickar A, Kluzik A, Weiler N, Scholz J, Tonner PH, Bein B. A comparison of auditory evoked potentials derived from a monitor integrated module versus standard technique. J Neurosurg Anesthesiol. 2009 Apr;21(2):120-6. doi: 10.1097/ANA.0b013e3181990d00.

  PMID: 19295390 BACKGROUND

• Ferreira AL, Mendes JG, Nunes CS, Amorim P. [Evaluation of Bispectral Index time delay in response to anesthesia induction: an observational study]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):377-382. doi: 10.1016/j.bjan.2019.03.008. Epub 2019 Jul 29.

  PMID: 31371175 BACKGROUND

• Zhong Q, Chen X, Zhao Y, Liu R, Yao S. Association of Polymorphisms in Pharmacogenetic Candidate Genes with Propofol Susceptibility. Sci Rep. 2017 Jun 13;7(1):3343. doi: 10.1038/s41598-017-03229-3.

  PMID: 28611364 BACKGROUND

• Fan J, Zhou Q, Li Y, Song X, Hu J, Qin Z, Tang J, Tao T. Profiling of Long Non-coding RNAs and mRNAs by RNA-Sequencing in the Hippocampi of Adult Mice Following Propofol Sedation. Front Mol Neurosci. 2018 Mar 23;11:91. doi: 10.3389/fnmol.2018.00091. eCollection 2018.

  PMID: 29628875 BACKGROUND

• Hallqvist L, Martensson J, Granath F, Sahlen A, Bell M. Intraoperative hypotension is associated with myocardial damage in noncardiac surgery: An observational study. Eur J Anaesthesiol. 2016 Jun;33(6):450-6. doi: 10.1097/EJA.0000000000000429.

  PMID: 26950081 BACKGROUND

MeSH Terms

Interventions

Remifentanil; Rocuronium

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• SanQing Jin, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 20, 2020
• Study Start: October 23, 2020
• Primary Completion: March 25, 2021
• Study Completion: April 25, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)