Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia

Pain Clinical Trial

— SPIDER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218306
• Other study ID #: SPI_3417
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2017
• Last updated: October 24, 2017
• Start date: October 23, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: October 2017
• Source: University of Cagliari
• Contact: Paolo Onida, MD
• Phone: +3907051096543
• Email: paolo.onida80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain
• Surgery

Intervention

Device:
• Surgical Pleth Index
Effector site concentration of remifentanil based on SPI

Other:
• Clinical guidance
Effector site concentration of remifentanil based on hemodynamic data

Locations

Country	Name	City	State
Italy	Policlinico Duilio Casula	Monserrato	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

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