N/A
Completed N=69
Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia
Source: ClinicalTrials.gov NCT00789438 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints — 46; 67; 40 SPI and delta SPI (to baseline)
Summary
The Surgical Pleth index (SPI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints |
46; 67; 40 | — |
Eligibility Criteria
Inclusion Criteria
- surgical procedures feasible under general or spinal anesthesia
- duration between 30 and 90 min
- ASA status I,II or III
Exclusion Criteria
- contraindications against one of the anesthesia methods
- age under 18
- emergencies
- chronical pain history
- lack of sinus rhythm
Data sourced from ClinicalTrials.gov (NCT00789438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.