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
1 other identifier
interventional
198
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 26, 2017
October 1, 2017
11 months
July 9, 2017
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remifentanil consumption
Cumulative remifentanil consumption throughout surgery
Intraoperative
Secondary Outcomes (7)
Hemodynamics
intraoperative
Desflurane
intraoperative
Extubation delay
intraoperative
Post-operative analgesia 1
24 hr post operative
Post-operative analgesia 2
24 hr post operative
- +2 more secondary outcomes
Study Arms (2)
SPI guided analgesia
EXPERIMENTALSPI ≤ 10 percentual points over the post-induction/pre-surgical incision value
Clinical Guided Analgesia
ACTIVE COMPARATORNo SPI guidance
Interventions
Effector site concentration of remifentanil based on SPI
Effector site concentration of remifentanil based on hemodynamic data
Eligibility Criteria
You may qualify if:
- \<age\<80 years
- American society of anesthesiology (ASA) physical status I -II
- hrs fasting
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Duilio Casula
Monserrato, Cagliari, 09072, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gabriele Finco, MD
University of Cagliari
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology and Intensive Care
Study Record Dates
First Submitted
July 9, 2017
First Posted
July 14, 2017
Study Start
October 23, 2017
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
October 26, 2017
Record last verified: 2017-10