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

Dose Surgical Pleth Index Play a Role to Predict Optimal Timing for Tracheal Intubation During Anesthetic Induction?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04608240
Enrollment
102
Registered
2020-10-29
Start date
2020-09-30
Completion date
2021-11-30
Last updated
2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trachea Intubation

Keywords

surgical pleth index, hemodynamic reactivity, trachea intubation

Brief summary

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.

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.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ability of SPI to predict hemodynamic reactivity after tracheal intubation in general populationwithin 2 minutes after trachea intubationThe area under receiver-operating characteristic curve (AUC) of SPI
ability of SPI to predict hemodynamic reactivity after tracheal intubation in femalewithin 2 minutes after trachea intubationThe area under receiver-operating characteristic curve (AUC) of SPI
ability of SPI to predict hemodynamic reactivity after tracheal intubation in malewithin 2 minutes after trachea intubationThe area under receiver-operating characteristic curve (AUC) of SPI

Secondary

MeasureTime frameDescription
influence factors of hemodynamic reactivitywithin 2 minutes after trachea intubationusing logistic regression model
Cardiovascular stress levelwithin 2 minutes after trachea intubationdelta rate pressure product (ΔRPP) between different ranges of SPI

Countries

China

Contacts

Primary ContactJun Zhang, PhD
snapzhang@aliyun.com86-21-64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026