AnesthesiaSPIDERNCT03218306
Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia
A study testing Surgical Pleth Index and Clinical guidance in people with Anesthesia and Pain, run by University of Cagliari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Pain, Surgery
- What is being tested?
- Surgical Pleth Index and Clinical guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteItaly
- Study dates
- 23 Oct 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18<age<80 years
- American society of anesthesiology (ASA) physical status I -II
- 6 hrs fasting
Who cannot join
- 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
Show all 12Show fewer
- Hypertension (if not treated)
- Connective tissue disease
- Pregnancy
- Allergy or hypersensitivity to study drugs
- QT prolongation
- Absence of inclusion criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Duilio Casula
Monserrato, Cagliari, 09072
Paolo Mura, MD, +39 3476527512, mura_paolo@hotmail.com
Paolo Onida, MD
About this study
Official title: Surgical Pleth Index Guided Intraoperative Analgesia Versus Standard Clinical Approach During Desflurane Based General Anesthesia for Thyroidectomy
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.
- Conditions
- Anesthesia, Pain, Surgery
- Being tested
- Surgical Pleth Index, Clinical guidance
- Keywords
- SPI, Remifentanil, Target controlled infusion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Pleth IndexDevice
Effector site concentration of remifentanil based on SPI
Clinical guidanceOther
Effector site concentration of remifentanil based on hemodynamic data
| Study group | Role | What they receive |
|---|---|---|
| SPI guided analgesia | Experimental | SPI ≤ 10 percentual points over the post-induction/pre-surgical incision value Receives: Device: Surgical Pleth Index |
| Clinical Guided Analgesia | Active comparator | No SPI guidance Receives: Other: Clinical guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil consumption
Cumulative remifentanil consumption throughout surgery
Measured: Intraoperative
Secondary outcomes (7)
Hemodynamics
Cumulative number of episodes of hypotension or hypertension or brady/tachycardia
Measured: intraoperative
Desflurane
Cumulative consumption of desflurane (ml) as measured by datex ohmeda aysis ventilator
Measured: intraoperative
Extubation delay
Timespan between end of surgery and extubation
Measured: intraoperative
Post-operative analgesia 1
Evaluate the total consumption of analgesics in the first 24 hours after surgery
Measured: 24 hr post operative
Post-operative analgesia 2
measure pain in the first post-operative day
Measured: 24 hr post operative
Adverse reactions
Nausea and vomiting in the 1st post-operative day
Measured: 24 hr post operative
Patient satisfaction
Evaluate on a 0-4 numeric scale patient satisfaction
Measured: 24 hr post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start23 Oct 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Gabriele Finco, University of Cagliari
- Investigators
- Gabriele Finco, MD, Study director, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218306
- Sponsor's protocol ID
- SPI_3417
- Acronym
- SPIDER
- Status last verified
- Oct 2017
- First submitted
- 9 Jul 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Pleth Index Guided Intraoperative Analgesia Versus Standard Clinical Approach During Desflurane Based General Anesthesia for Thyroidectomy
- ClinicalTrials.gov ID
- NCT03218306
- Acronym / sponsor ID
- SPIDER / SPI_3417
- Conditions
- Anesthesia, Pain, Surgery
- Keywords
- SPI, Remifentanil, Target controlled infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI guided analgesia | Experimental | Device: Surgical Pleth IndexSPI ≤ 10 percentual points over the post-induction/pre-surgical incision value |
| Clinical Guided Analgesia | Active comparator | Other: Clinical guidanceNo SPI guidance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18<age<80 years
- American society of anesthesiology (ASA) physical status I -II
- 6 hrs fasting
Key exclusion criteria (12 listed)
- Arrhythmia or Pacemaker
- Central or peripheral nervous system or muscular disease
- Drugs active on autonomous nervous system (eg clonidine)
- Obesity (BMI >35)
- Chronic Pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Pleth IndexEffector site concentration of remifentanil based on SPI | Device | SPI guided analgesia |
| Clinical guidanceEffector site concentration of remifentanil based on hemodynamic data | Other | Clinical Guided Analgesia |
Primary outcome
Remifentanil consumption
Time frame: Intraoperative
Cumulative remifentanil consumption throughout surgery
7 secondary outcomes
Hemodynamics
Time frame: intraoperative
Desflurane
Time frame: intraoperative
Extubation delay
Time frame: intraoperative
Post-operative analgesia 1
Time frame: 24 hr post operative
Post-operative analgesia 2
Time frame: 24 hr post operative
Adverse reactions
Time frame: 24 hr post operative
Patient satisfaction
Time frame: 24 hr post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Finco, MD study director
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Pleth Index and Clinical guidance in people with Anesthesia and Pain, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Onida, MD (+3907051096543, paolo.onida80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil consumption (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.