Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia

Study Overview
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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.

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

Conditions
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Anesthesia, Pain, Surgery

Intervention / Treatment
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* Device: Surgical Pleth Index
* Other: Clinical guidance


Participation Criteria
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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 Absence of inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPI, Remifentanil, Target controlled infusion