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Correlation between Surgical Pleth Index and acute postoperative pain in the recovery room

Surgical patients: observation of intra-operative surgical pleth index and its correlation with acute postoperative pain

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000804583
Enrollment
70
Registered
2015-08-03
Start date
2015-08-14
Completion date
2015-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Surgical Pleth Index (SPI, GE Healthcare) has been suggested to be a potentially useful parameter to assess the depth of analgesia (freedom of pain) in patients under general anaesthesia. SPI is completely risk free and requires no extra monitoring as is simply uses existing data from standard anaesthesia monitoring (from peripheral oxygen saturation sensor) to calculate a 0-100 analgesia score. Though experiments have shown that SPI scores may “respond” (i.e. going up with a painful stimulus), it is unclear whether the score may be useful to predict acute postoperative pain the recovery room. Aim of this purely observational study is to monitor SPI in 70 patients scheduled for elective surgery and to observe and record SPI data during the last approx.15 minutes of surgery until the patient wakes up from anaesthesia. This data will be compared with the first 15 minutes of 3-minutely assessed postoperative pain (0-10 numeric rating scale) in the recovery room (time counting from when patients are capable of pain self-rating). All assessments of interest for this study are standard practice of intraoperative monitoring and no additional monitoring is required for this study. The sole difference to standard practice is that the data from the anaesthesia monitor will be downloaded onto a laptop PC for analysis of the correlation between SPI and postoperative acute pain scores

Interventions

observation of surgical pleth index over the last 15 minutes of anaesthesia and observation of pain scores (on 0-10 numeric rating scale) during the first 15 minutes in the recovery room.

Sponsors

Thomas Ledowski
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

Patients scheduled for elective or urgent surgery under general anaesthesia (including laryngeal mask airway [if planned to be removed in the operating theatre] or endotracheal tube, state entropy monitoring) with sevoflurane. Age: 18 -95 yrs.

Exclusion criteria

Incapacity to consent, age < 18 yrs, poorly treated diabetes, severe peripheral or cardiac neuropathy, pacemaker, treatment (infusion) with vasoactive medication, ketamine during the data acquisition interval, any intraoperative treatment with ketamine, beta-receptor blockers, clonidine, beta-receptor agonists (i.e. Ventolin) or any other drug suspected to interact with the sympatho-vagal balance. Surgery requiring a tourniquet (unless already deflated at start of intra-operative data acquisition interval).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026