Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia

Not Applicable

• Conditions: Pain; Anesthesia; Surgery
• Interventions: Device: Surgical Pleth Index; Other: Clinical guidance

• Registration Number: NCT03218306
• Lead Sponsor: University of Cagliari

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 available

Study Timeline

• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Status Verified: 2017-10
• Study Start: 2017-10-23
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPI guided analgesia	Surgical Pleth Index	SPI ≤ 10 percentual points over the post-induction/pre-surgical incision value
Clinical Guided Analgesia	Clinical guidance	No SPI guidance

Primary Outcome Measures

Name	Time	Method
Remifentanil consumption	Intraoperative	Cumulative remifentanil consumption throughout surgery

Secondary Outcome Measures

Name	Time	Method
Hemodynamics	intraoperative	Cumulative number of episodes of hypotension or hypertension or brady/tachycardia
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
Post-operative analgesia 2	24 hr post operative	measure pain in the first post-operative day
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

Trial Locations

Locations (1)

Policlinico Duilio Casula; 🇮🇹 Monserrato, Cagliari, Italy