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Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia

NCT ID: NCT03218306

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2018-12-01

Brief Summary

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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

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Conditions

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Anesthesia Pain Surgery

Keywords

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SPI Remifentanil Target controlled infusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SPI guided analgesia

SPI ≤ 10 percentual points over the post-induction/pre-surgical incision value

Group Type EXPERIMENTAL

Surgical Pleth Index

Intervention Type DEVICE

Effector site concentration of remifentanil based on SPI

Clinical Guided Analgesia

No SPI guidance

Group Type ACTIVE_COMPARATOR

Clinical guidance

Intervention Type OTHER

Effector site concentration of remifentanil based on hemodynamic data

Interventions

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Surgical Pleth Index

Effector site concentration of remifentanil based on SPI

Intervention Type DEVICE

Clinical guidance

Effector site concentration of remifentanil based on hemodynamic data

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Prof. Gabriele Finco

Professor of Anesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriele Finco, MD

Role: STUDY_DIRECTOR

University of Cagliari

Locations

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Policlinico Duilio Casula

Monserrato, Cagliari, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Onida, MD

Role: CONTACT

Phone: +3907051096543

Email: [email protected]

Paolo Mura, MD

Role: CONTACT

Phone: +3907051096543

Email: [email protected]

Facility Contacts

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Paolo Mura, MD

Role: primary

Other Identifiers

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SPI_3417

Identifier Type: -

Identifier Source: org_study_id