Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration [PUP-AIT]. A Double Blinded Randomized Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Postoperative pain
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
In this double blinded randomized controlled study, the pupillary dilation reflex is used for as a nociceptive indicator for opioid administration during elective surgery under general anesthesia.
Detailed Description
An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, ...) The PDR is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic stimulation. This double blind randomized controlled trial involving American Society of Anesthesiologists (ASA) classification I-III patients undergoing elective surgery under general anesthesia are recruited. Enrolled patients are randomized in four groups: (1) remifentanil administration depending on PDR results, (2) remifentanil administration depending on decision attending anesthesiologist, (3) sufentanil administration depending on PDR results, (4) sufentanil administration depending on decision attending anesthesiologist.
Investigators
Davina Wildemeersch
Principle investigator
University Hospital, Antwerp
Eligibility Criteria
Inclusion Criteria
- •\> 18 jaar
- •Elective abdominal or gynaecological operation
- •ASA (American Society of Anesthesiologists classification): I - II - III
Exclusion Criteria
- •History of invasive ophthalmological surgery
- •Known bilateral eye disease
- •Known optical of oculomotor nerve deficit
- •Active psychiatrical disease
- •Proven active pheochromocytoma
- •Opioid usage \> 7 days preoperative
- •Ongoing oncological treatment with chemotherapeutic agents
- •Usage of A-1 adrenergic of beta-blocking agents
- •Preoperative usage of benzodiazepines
- •Topical atropine or phenylephrine (eye droplets)
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: From patient extubation until postoperative day 5
Numeric rating scale (NRS) pain assessment
Postoperative analgesia
Time Frame: From patient extubation until postoperative day 5
Analgetic consumption
Secondary Outcomes
- Stimulation intensity to elicit PDR(From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours)
- Baseline pupil diameter(From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours)
- Pupillary dilation reflex amplitude(From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours)
- Pupillary pain index (PPI)(From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours)
- Opioid usage during surgery(From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours)
- Extubation time(From the day of surgery at the termination of propofol infusion until patient extubation, assessed up to 2 hours)
- Postoperative nausea and vomiting(From patient extubation until postoperative day 5)
- Length of stay at the postanesthesia care unit(From admission at the postanesthesia care unit until discharge to the nursing ward, assessed up to 24 hours)
- Length of hospital stay(From the day of the planned surgery until hospital discharge, assessed up to 5 days)
- Postoperative health status(From extubation until 1 month after surgery)