Surgical Pleth Index (SPI) Versus Standard Clinical Appro... | NCT03218306

Studies
Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia

NCT03218306

Sponsor

University of Cagliari

Status

Unknown status

Last Update Posted

Oct 26, 2017Actual

Enrollment

198Estimated

Phase

Not Applicable

Conditions

Anesthesia
Pain
Surgery

Interventions

Surgical Pleth Index
Clinical guidance

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2017Actual

Primary Completion Date

Oct 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Jul 9, 2017

First Submission Date that Met QC Criteria

Jul 12, 2017

First Posted Date

Jul 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2017

Last Update Posted Date

Oct 26, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Gabriele Finco, Professor of Anesthesiology and Intensive Care, University of CagliariPrincipal Investigator

Lead Sponsor

University of CagliariOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is aimed at confronting a surgical pleth index based protocol for intraoperative analgesia in a desflurane based general anesthesia for thyroidectomy, versus a standard clinical approach. A reduction in analgesic consumption and improvement in hemodynamics are expected.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPI guided analgesia	Experimental	SPI ≤ 10 percentual points over the post-induction/pre-surgical incision value	Device: Surgical Pleth Index
Clinical Guided Analgesia	Active Comparator	No SPI guidance	Other: Clinical guidance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical Pleth Index	Device	Effector site concentration of remifentanil based on SPI	SPI guided analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Remifentanil consumption	Cumulative remifentanil consumption throughout surgery	Intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Hemodynamics	Cumulative number of episodes of hypotension or hypertension or brady/tachycardia	intraoperative
Desflurane	Cumulative consumption of desflurane (ml) as measured by datex ohmeda aysis ventilator

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18<age<80 years
American society of anesthesiology (ASA) physical status I -II
6 hrs fasting

Exclusion Criteria:

Arrhythmia or Pacemaker
Central or peripheral nervous system or muscular disease
Drugs active on autonomous nervous system (eg clonidine)
Obesity (BMI >35)
Chronic Pain
Addictions or central nervous acting drugs use
Hypertension (if not treated)
Connective tissue disease
Pregnancy
Allergy or hypersensitivity to study drugs
QT prolongation
Absence of inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paolo Onida, MD	Contact	+3907051096543		paolo.onida80@gmail.com
Paolo Mura, MD	Contact	+3907051096543		mura_paolo@hotmail.com

Overall Officials

Name	Affiliation	Role
Gabriele Finco, MD	University of Cagliari	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Duilio Casula	Recruiting	Monserrato	Cagliari	09072	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

Not provided