Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia

Surgical Pleth Index Guided Intraoperative Analgesia Versus Standard Clinical Approach During Desflurane Based General Anesthesia for Thyroidectomy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03218306

Acronym

SPIDER

Enrollment

198

Registered

2017-07-14

Start date

2017-10-23

Completion date

2018-12-01

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Pain, Surgery

Keywords

SPI, Remifentanil, Target controlled infusion

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.

Interventions

DEVICESurgical Pleth Index

Effector site concentration of remifentanil based on SPI

OTHERClinical guidance

Effector site concentration of remifentanil based on hemodynamic data

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Desflurane	intraoperative	Cumulative consumption of desflurane (ml) as measured by datex ohmeda aysis ventilator
Extubation delay	intraoperative	Timespan between end of surgery and extubation
Post-operative analgesia 1	24 hr post operative	Evaluate the total consumption of analgesics in the first 24 hours after surgery
Hemodynamics	intraoperative	Cumulative number of episodes of hypotension or hypertension or brady/tachycardia
Adverse reactions	24 hr post operative	Nausea and vomiting in the 1st post-operative day
Patient satisfaction	24 hr post operative	Evaluate on a 0-4 numeric scale patient satisfaction
Post-operative analgesia 2	24 hr post operative	measure pain in the first post-operative day

Countries

Italy

Contacts

Primary ContactPaolo Onida, MD

paolo.onida80@gmail.com+3907051096543

Backup ContactPaolo Mura, MD

mura_paolo@hotmail.com+3907051096543

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026