An interventional study of Surgical Pleth Index and Clinical guidance in Anesthesia, Pain and Surgery, sponsored by University of Cagliari. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by University of Cagliari · Not applicable, Interventional, and Treatment
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.
University of Cagliari is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SPI ≤ 10 percentual points over the post-induction/pre-surgical incision value
Device: Surgical Pleth Index
No SPI guidance
Other: Clinical guidance
Effector site concentration of remifentanil based on SPI
Effector site concentration of remifentanil based on hemodynamic data
Remifentanil consumption
Cumulative remifentanil consumption throughout surgery
Time frame: Intraoperative
Hemodynamics
Cumulative number of episodes of hypotension or hypertension or brady/tachycardia
Time frame: intraoperative
Desflurane
Cumulative consumption of desflurane (ml) as measured by datex ohmeda aysis ventilator
Time frame: intraoperative
Extubation delay
Timespan between end of surgery and extubation
Time frame: intraoperative
Post-operative analgesia 1
Evaluate the total consumption of analgesics in the first 24 hours after surgery
Time frame: 24 hr post operative
Post-operative analgesia 2
measure pain in the first post-operative day
Time frame: 24 hr post operative
Adverse reactions
Nausea and vomiting in the 1st post-operative day
Time frame: 24 hr post operative
Patient satisfaction
Evaluate on a 0-4 numeric scale patient satisfaction
Time frame: 24 hr post operative
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Cagliari