Surgical Pleth Index: Predicting the Optimal Timing for Tracheal Intubation During General Anesthesia

Overview

Surgical pleth index (SPI) has been widely investigated in assessing the nociceptive level, and tracheal intubation is a noxious stimulus during the induction of anesthesia. This study aims to evaluate the ability of SPI to predict hemodynamic reactivity after tracheal intubation, and find the target value of SPI to guide the optimal timing for tracheal intubation.

Full Title of Study: “Dose Surgical Pleth Index Play a Role to Predict Optimal Timing for Tracheal Intubation During Anesthetic Induction?”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 28, 2021

Detailed Description

The surgical pleth index (SPI)monitored by a oxygen saturation (Spo2) probe, is a dimensionless score which is based on the photoplethysmographic analysis of the pulse wave and the heartbeat interval. SPI score monitored during surgery is the indicator that may reflect a patient's autonomic response to certain noxious stimulus and is correlated to his/her nociception level. Once noxious stimulus occur, sympathetically-mediated vasoconstriction and cardiac autonomic tone increasing can be reflected by SPI. Several studies have since investigated the potential benefits of SPI-guided anesthesia, such as SPI could reduce the intraoperative opioid consumption and facilitate extubation after surgery.Jain N et al. found that the need for postoperative analgesics decreased although fentanyl consumption increased, when SPI guided opioid use Intraoperatively . The level of SPI was also reported to be able to predict postoperative pain, which could guide clinical use of opioids and improve patient postoperative satisfaction. Recent studies on SPI mainly focus on the maintenance period of anesthesia and postoperative analgesia, and there is few studies on the application of SPI in anesthesia induction period. Hemodynamic stability in induction period has always been the technical key point that anesthesiologists pay attention to, especially for patients with cardiovascular and cerebrovascular diseases, maintaining hemodynamic stability is particularly important. Endotracheal intubation is a common procedure during general anesthesia. The hemodynamic fluctuation caused by intubation stimulation is usually caused by the premature timing of intubation. At present, the timing of intubation is much depended on the clinical experience of an anesthesiologist, such as according to the degree of blood pressure, heart rate decline or predicted onset of propofol,opioid and neuromascular blocker. This study aims to explore whether the SPI can be used in quantitative prediction of intubation timing or prediction the hemodynamic reactivity after intubation, and to investigate the influence of age and gender on SPI value.

Clinical Trial Outcome Measures

Primary Measures

  • ability of SPI to predict hemodynamic reactivity after tracheal intubation in general population
    • Time Frame: within 2 minutes after trachea intubation
    • The area under receiver-operating characteristic curve (AUC) of SPI
  • ability of SPI to predict hemodynamic reactivity after tracheal intubation in female
    • Time Frame: within 2 minutes after trachea intubation
    • The area under receiver-operating characteristic curve (AUC) of SPI
  • ability of SPI to predict hemodynamic reactivity after tracheal intubation in male
    • Time Frame: within 2 minutes after trachea intubation
    • The area under receiver-operating characteristic curve (AUC) of SPI

Secondary Measures

  • influence factors of hemodynamic reactivity
    • Time Frame: within 2 minutes after trachea intubation
    • using logistic regression model
  • Cardiovascular stress level
    • Time Frame: within 2 minutes after trachea intubation
    • delta rate pressure product (ΔRPP) between different ranges of SPI

Participating in This Clinical Trial

Inclusion Criteria

  • American Society of Anesthesiology physical status (ASA) 1-2 – Patients aged 18-80 years undergoing non-emergency anesthesia Exclusion Criteria:

  • age <18 years – severe peripheral or cardiac neuropathy – significant arrhythmia (i.e. atrial fibrillation or atrioventricular block) – pacemaker – neurovascular diseases – uncontrolled hypertension – treatment with vasoactive medication during the induction of anesthesia – any intraoperative treatment with beta receptor blockers, clonidine, beta receptor agonists, or any other drug suspected to interact with the sympathovagal balance – predicted difficult ventilation – chronic pain requiring long-term analgesics – addictive to opioids.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jun Zhang, Director of the department of anaesthesiology, Shanghai cancer center – Fudan University
  • Overall Official(s)
    • Jun Zhang, PhD, Principal Investigator, Fudan University
  • Overall Contact(s)
    • Jun Zhang, PhD, 86-21-64175590, snapzhang@aliyun.com

References

Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.

Struys MM, Vanpeteghem C, Huiku M, Uutela K, Blyaert NB, Mortier EP. Changes in a surgical stress index in response to standardized pain stimuli during propofol-remifentanil infusion. Br J Anaesth. 2007 Sep;99(3):359-67. doi: 10.1093/bja/aem173. Epub 2007 Jul 3.

Bergmann I, Gohner A, Crozier TA, Hesjedal B, Wiese CH, Popov AF, Bauer M, Hinz JM. Surgical pleth index-guided remifentanil administration reduces remifentanil and propofol consumption and shortens recovery times in outpatient anaesthesia. Br J Anaesth. 2013 Apr;110(4):622-8. doi: 10.1093/bja/aes426. Epub 2012 Dec 5.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.