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Analgesic Depth Evaluation During General Anesthesia With Dexmedetomidine-remifentanil Infusion. A Pilot Study

Intraoperative Assessment of Analgesic Depth During General Anesthesia With Dexmedetomidine-remifentanil Infusion. A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05785273
Enrollment
45
Registered
2023-03-27
Start date
2019-02-19
Completion date
2019-08-01
Last updated
2023-03-27

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

Conditions

Analgesia, Anesthesia

Keywords

Dexmedetomidine, Pupil, Nociception, Opioid sparing

Brief summary

The aim of this study is to verify the feasibility of an evaluation of the depth of analgesia during an opioid sparing anesthesia (OSA) carried out with continuous infusion of dexmedetomidine in addition to general multimodal anesthesia trough an instrumental pupillary evaluation.

Detailed description

In recent years, different strategies have been proposed to reduce opioid use during the perioperative period, i.e., the so-called OFA (opioid free anesthesia) or OSA (opioid sparing anesthesia), in order to reduce some opioid-related side effects with equivalent intraoperative analgesia compared to opioid-based anesthesia. Dexmedetomidine is a highly selective α2-agonist, with sedative and pain-relieving effects. The use of perioperative dexmedetomidine seems to reduce intraoperative opioid and hypnotic consumption, postoperative pain intensity and postoperative opioid use. A dexmedetomidine-based protocol for anesthesia in obese patients was introduced in our department towards the end of 2018. All patients undergoing bariatric surgery have been treated with a premedication of dexmedetomidine and a steady infusion of dexmedetomidine as an opioid-savings adjuvant during general anesthesia. In this context, the amount of fentanyl (induction of anesthesia) and remifentanil (maintenance of anesthesia) has been reduced empirically and clinically. Traditionally, during general anesthesia, the level of nociception is indirectly assessed by observing heart rate, blood pressure and surgical steps. In recent years, new indicators have been proposed to obtain an objective and standardized nociception assessment. Pupillary dilation reflex (PDR) can be related to both painful stimulation and analgesic depth, but not to neuromuscular blockade or hypnotic drug administration. Recently, another rating scale for nociception has been proposed: the PPI (pupillary pain index). This index is based on tetanic stimulation of increasing intensity delivered by two skin electrodes placed on the forearm, evaluating the PDR at each stimulus. A PPI from 1 to 3, from 4 to 6, or from 7 to 9 describes a numbed PDR and deep analgesia, a medium PDR and suboptimal analgesia and a highly reactive PDR and uncontrolled pain, respectively. The investigators proposal is to study the feasibility of an evaluation of the nociception during an Opioid Sparing Anesthesia (OSA), with continuous infusion of dexmedetomidine and remifentanil, vs traditional anesthesia without adjuvant, using the PPI as an indicator of nociception.

Interventions

1st pupil evaluation between induction of general anesthesia and onset of surgery. After incision, at least 3 pupil evaluations are performed. Measurements are spaced 15 minutes apart and also taken at least 10 minutes after any variation in drugs dosage

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
CollaboratorOTHER
Università degli Studi di Brescia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients underwent open surgery involving at least one surgical incision of more than 5 cm * use of remifentanil as an intravenous analgesic.

Exclusion criteria

* implanted pacemaker or ICD * ophthalmological comorbidities * chronic opioid use * peripheral neuropathy * continuous infusion of adjuvant drugs other than dexmedetomidine * epidural analgesia or loco-regional block

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of study protocol6 monthsNumber of patients enrolled and number of pupillary evaluation during anesthesia

Secondary

MeasureTime frameDescription
Depth of analgesiaIntraoperativedepth of intraoperative analgesia with PPI (pupillary pain index). A PPI from 1 to 3, from 4 to 6, or from 7 to 9 describes a numbed PDR and deep analgesia, a medium PDR and suboptimal analgesia and a highly reactive PDR and uncontrolled pain, respectively.
Intra-operative opioid consumptionIntraoperativetotal consumption of remifentanil (μg/kg/min - Lean Body Weight)
Incidence of side effectsIntraoperativeincidence of perioperative side effects, PONV and post-operative intolerable pain in the first 24 hours after surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026