The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery

Surgical Pleth Index (SPI) is an intraoperative monitor aimed into detection of nociception and guidance of intraoperative opioid administration. Using such a device opioid administration could be potentially optimized during intraoperative period. this study will aim to show whether SPI could be used to reduce unwanted events and lower opioid consumption in gastroenterological surgery. The study will be blinded and randomized including two study arms with either SPI monitoring included or standard monitoring alone.

Study Overview

• Status: Completed
• Conditions: Intraoperative Complications; Intraoperative Hypotension; Intraoperative Hypertension
• Intervention / Treatment: Device: SPI; Device: Standard

Detailed Description

Patients are extensively monitored intraoperatively. Even though there are monitors for the measurement of nociception, it has not gained wide acceptance partly because of limited and scarce evidence on the efficacy and optimal use. Especially elderly patients undergoing major operation might benefit from optimization of opioid administration. Surgical Pleth Index (SPI) is an intraoperative monitoring aimed for detection of nociceptive stimulus.

The aim of this research is to study whether SPI could be used to guide opioid administration in gastroenterological surgery. The study will consist of a total 80 patients which are randomized into two groups. The study sample is based on power calculation for the reduction of remifentanil consumption.

In the study group the opioid administration will be guided using a SPI based protocol. In the control group the opioid administration will be based on standard monitoring and clinical decision alone. The aim of the study will be to study whether opioid administration optimized using SPI can lover need for anticholinergic drugs, reduce need for opioids or diminish the amount of unwanted side effects postoperatively. The patients will be treated using target controlled infusions of remifentanil and propofol.

The data will be collected intraoperatively using electronic software and using a study data collection form by study personel. All study procedures will take place during operative period.

The study power was calculated using a study comparing depth of anesthesia and depth of nociception balance-controlled group into a group without these monitors. In the group with monitoring the consumption of remifentanil was 9,5±3.8 mg/kg/h while in the unmonitored group the consumption was 12.3 mg/kg/h(Chen, 2010). While taking into notice α= 0,005 and β=90% a number of 39 patients in each group is needed. Based on these we chose 80 patients to be included in the study.

All collected data will be used into statistical analysis ass applicable. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to provide a written informed consent
• Age 50 years or above
• Laparoscopic or laparotomic surgery requiring intubation with an expected intraoperative time at least two hours.
• ASA classification 1-3

Exclusion Criteria:

• Implanted cardiac pacemaker or known condition with irregular heart rate at the time of inclusion or induction
• Chronic use of opioids
• BMI >35
• Known allergy for study medications
• Over 5 extrasystoles per minute at the time of induction or inclusion
• The use of epidural catheter during the last one hour before surgery or need for catheter intraoperatively (if new catheter is placed at the beginning of surgery test dosage may be used without the need for patient exclusion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SPI group; Group of patients where opioid consumption will be guided using SPI target	Device: SPI; Either standard monitoring alone or added with SPI
Active Comparator: Control Group; Group of patients where only standard monitoring and patient reaction will be used to guide opioid administration during intraoperative period	Device: Standard; Standard monitoring alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative remifentanil consumption	The consumption of the remifentanil intraoperatively	intraoperative time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severe hypotension	MAP <55 mmHg, or -30% from the baseline value	intraoperative time
intermediate hypotension	MAP <65 mmHg, or -20% from the baseline value	intraoperative time
hypertension	RRsys >140 mmHg or +20 % from baseline value	intraoperative time
Bradycardia	Heart rate<45	intraoperative time
tachycardia	Heart rate>90	intraoperative time
Inraoperative propofol consumption		intraoperative time
Desorientation/ grade of sedation during postoperative care treatment	The postoperative desoroentation during immediate post-operative period at postanesthesia care unit. Measured using modified aldrete score	2-4 hours
Postoperative nausea and vomiting	The postoperative nausea and vomiting during immediate post-operative period at postanesthesia care unit. Measured using modified aldrete score.	2-4 hours
Postoperative opioid consumption	The postoperative opioid consumption during immediate post-operative period at postanesthesia care unit.	2-4 hours
Fading of intraoperative relaxation	The characteristics of intraoperative relaxation using EMG measurement	intraoperative time

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: general electric healthcare Finland
• Investigators: Principal Investigator: Jarkko Harju, MD, PhD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Nociception; Intraoperative monitoring; Surgical pleth index
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hypotension; Intraoperative Complications
• Other Study ID Numbers: R20006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No