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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Surgery; Anesthesia
• Intervention / Treatment: Device: Surgical Pleth Index; Other: Clinical guidance

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Onida, MD; Phone Number: +3907051096543; Email: paolo.onida80@gmail.com
• Study Contact Backup: Name: Paolo Mura, MD; Phone Number: +3907051096543; Email: mura_paolo@hotmail.com

Study Locations

• Italy
  • Cagliari
    • Monserrato, Cagliari, Italy, 09072
      • Recruiting
      • Policlinico Duilio Casula
      • Contact: Paolo Mura, MD; Phone Number: +39 3476527512; Email: mura_paolo@hotmail.com
      • Principal Investigator: Paolo Onida, MD
      • Sub-Investigator: Paolo Mura, MD
      • Sub-Investigator: Tiziana Cabras, RN
      • Sub-Investigator: Riccardo Pili, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPI guided analgesia; SPI ≤ 10 percentual points over the post-induction/pre-surgical incision value	Device: Surgical Pleth Index; Effector site concentration of remifentanil based on SPI
Active Comparator: Clinical Guided Analgesia; No SPI guidance	Other: Clinical guidance; Effector site concentration of remifentanil based on hemodynamic data

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	intraoperative
Extubation delay	Timespan between end of surgery and extubation	intraoperative
Post-operative analgesia 1	Evaluate the total consumption of analgesics in the first 24 hours after surgery	24 hr post operative
Post-operative analgesia 2	measure pain in the first post-operative day	24 hr post operative
Adverse reactions	Nausea and vomiting in the 1st post-operative day	24 hr post operative
Patient satisfaction	Evaluate on a 0-4 numeric scale patient satisfaction	24 hr post operative

Collaborators and Investigators

• Sponsor: University of Cagliari
• Investigators: Study Director: Gabriele Finco, MD, University of Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Remifentanil; Target controlled infusion; SPI
• Other Study ID Numbers: SPI_3417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

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