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

University of Cagliari

Status: Unknown

Conditions: Surgery; Pain; Anesthesia

Treatments: Device: Surgical Pleth Index; Other: Clinical guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT03218306

SPI_3417

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

SPI guided analgesia

Experimental group

Description:

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

Treatment:

Device: Surgical Pleth Index

Clinical Guided Analgesia

Active Comparator group

Description:

No SPI guidance

Treatment:

Other: Clinical guidance