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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03218306
Date of registration:	09/07/2017
Prospective Registration:	Yes
Primary sponsor:	University of Cagliari
Public title:	Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia SPIDER
Scientific title:	Surgical Pleth Index Guided Intraoperative Analgesia Versus Standard Clinical Approach During Desflurane Based General Anesthesia for Thyroidectomy
Date of first enrolment:	October 23, 2017
Target sample size:	198
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03218306
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Italy

Contacts

Name:	Paolo Onida, MD
Address:
Telephone:	+3907051096543
Email:	paolo.onida80@gmail.com
Affiliation:

Name:	Gabriele Finco, MD
Address:
Telephone:
Email:
Affiliation:	University of Cagliari

Name:	Paolo Mura, MD
Address:
Telephone:	+39 3476527512
Email:	mura_paolo@hotmail.com
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18
- 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Anesthesia

Surgery

Intervention(s)

Device: Surgical Pleth Index

Other: Clinical guidance

Primary Outcome(s)

Remifentanil consumption [Time Frame: Intraoperative]

Secondary Outcome(s)

Post-operative analgesia 2 [Time Frame: 24 hr post operative]

Desflurane [Time Frame: intraoperative]

Adverse reactions [Time Frame: 24 hr post operative]

Hemodynamics [Time Frame: intraoperative]

Patient satisfaction [Time Frame: 24 hr post operative]

Extubation delay [Time Frame: intraoperative]

Post-operative analgesia 1 [Time Frame: 24 hr post operative]

Secondary ID(s)

SPI_3417

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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