NCT04519203

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 25, 2024

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

February 21, 2020

Last Update Submit

November 21, 2024

Conditions

Intraoperative ComplicationsIntraoperative HypotensionIntraoperative Hypertension

Keywords

NociceptionIntraoperative monitoringSurgical pleth index

Outcome Measures

Primary Outcomes (1)

  • Intraoperative remifentanil consumption

    The consumption of the remifentanil intraoperatively

    intraoperative time

Secondary Outcomes (10)

  • severe hypotension

    intraoperative time

  • intermediate hypotension

    intraoperative time

  • hypertension

    intraoperative time

  • Bradycardia

    intraoperative time

  • tachycardia

    intraoperative time

  • +5 more secondary outcomes

Study Arms (2)

SPI group

ACTIVE COMPARATOR

Group of patients where opioid consumption will be guided using SPI target

Device: SPI

Control Group

ACTIVE COMPARATOR

Group of patients where only standard monitoring and patient reaction will be used to guide opioid administration during intraoperative period

Device: Standard

Interventions

SPIDEVICE

Either standard monitoring alone or added with SPI

SPI group
StandardDEVICE

Standard monitoring alone

Control Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic use of opioids
  • BMI \>35
  • Known allergy for study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Intraoperative Complications

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Study Officials

  • Jarkko Harju, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients are randomized using sealed envelopes. The ramdomization will be kept blinded to the study subjects
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

August 19, 2020

Study Start

September 9, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 25, 2024

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)