Clinical trial NCT04608240: Surgical Pleth Index: Predicting the Optimal Timing for Tracheal Intubation During General Anesthesia
Official title: Dose Surgical Pleth Index Play a Role to Predict Optimal Timing for Tracheal Intubation During Anesthetic Induction?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trachea Intubation
Keywords: surgical pleth index
hemodynamic reactivity
trachea intubation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: American Society of Anesthesiology physical status (ASA) 1-2 and patients aged 18-80 years undergoing non-emergency anesthesia

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ability of SPI to predict hemodynamic reactivity after tracheal intubation in general population
timeFrame: within 2 minutes after trachea intubation
measure: ability of SPI to predict hemodynamic reactivity after tracheal intubation in female
timeFrame: within 2 minutes after trachea intubation
measure: ability of SPI to predict hemodynamic reactivity after tracheal intubation in male
timeFrame: within 2 minutes after trachea intubation
Secondary outcomes:
measure: influence factors of hemodynamic reactivity
timeFrame: within 2 minutes after trachea intubation
measure: Cardiovascular stress level
timeFrame: within 2 minutes after trachea intubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.