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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05785273
• Other study ID #: UBrescia NP 3675
• Status: Completed
• Start date: February 19, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2023
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia

Intervention

Device:
• Pupillometer
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

Locations

Country	Name	City	State
Italy	ASST Spedali Civili	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Brescia	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Grape S, Kirkham KR, Frauenknecht J, Albrecht E. Intra-operative analgesia with remifentanil vs. dexmedetomidine: a systematic review and meta-analysis with trial sequential analysis. Anaesthesia. 2019 Jun;74(6):793-800. doi: 10.1111/anae.14657. Epub 2019 Apr 5. — View Citation

Kim JH, Jwa EK, Choung Y, Yeon HJ, Kim SY, Kim E. Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial. Anesth Analg. 2020 Nov;131(5):1589-1598. doi: 10.1213/ANE.0000000000004958. — View Citation

Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study protocol	Number of patients enrolled and number of pupillary evaluation during anesthesia	6 months
Secondary	Depth of analgesia	depth 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.	Intraoperative
Secondary	Intra-operative opioid consumption	total consumption of remifentanil (µg/kg/min - Lean Body Weight)	Intraoperative
Secondary	Incidence of side effects	incidence of perioperative side effects, PONV and post-operative intolerable pain in the first 24 hours after surgery	Intraoperative