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

NCT05785273 | Completed

• 1 other identifier: UBrescia NP 3675
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Anesthesia

Keywords

Dexmedetomidine; Pupil; Nociception; Opioid sparing

Outcome Measures

Primary Outcomes (1)

• Feasibility of study protocol

  Number of patients enrolled and number of pupillary evaluation during anesthesia

  6 months

Secondary Outcomes (3)

• Depth of analgesia

  Intraoperative

• Intra-operative opioid consumption

  Intraoperative

• Incidence of side effects

  Intraoperative

Study Arms (2)

Dexmedetomidine

Patient undergoing general anesthesia receving initial administration of dexmedetomidine loading dose of 0.5-1 μg/kg (ADJUSTED weight) over 15 minutes. After intubation maintenance of general anesthesia is administrated with desflurane or sevoflurane (MAC 0.6 - 1, according to Bispectral Index (BIS) or Patient State Index (Psi)), dexmedetomidine (0.2- 0.4 μg/kg/h (Lean Body Weight)) with constant infusion rate unless hypotension or bradycardia not responsive to standard treatments (filling, atropine, ephedrine, ethylephrine) occurred, and remifentanil (0.02 - 0.2 μg/kg/min (LBW)) based on clinical and instrumental assessment (Heart Rate, Blood Pressure, BIS or Psi).

Device: Pupillometer

No Dexmedetomidine

Patients in this group receive an eventual premedication with benzodiazepines according to anaesthesiologist assessment and patient condition. After intubation general anesthesia is administrated with inhaled (desflurane or sevoflurane; MAC 0.6 - 1) or intravenous (propofol) anesthetics (according to BIS or Psi) and remifentanil (0.02 - 0.2 μg/kg/min (LBW) based on clinical and instrumental assessment (HR, BP, BIS or Psi)).

Device: Pupillometer

Interventions

Pupillometer DEVICE

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

Dexmedetomidine; No Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent no-laparoscopic surgery involving at least one surgical incision of more than 5 cm with remifentanil as an intravenous analgesic.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator

Study Sites (1)

ASST Spedali Civili

Brescia, 25121, Italy

Location

Related Publications (4)

• 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.

  PMID: 30950522 BACKGROUND

• 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.

  PMID: 28719527 BACKGROUND

• 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.

  PMID: 33079883 BACKGROUND

• Stefanini M, Cagnazzi E, Calza S, Latronico N, Rasulo FA. Feasibility of the pupillary pain index as a guide for depth of analgesia during opioid-sparing anesthesia with continuous infusion of dexmedetomidine. J Anesth Analg Crit Care. 2023 Aug 14;3(1):27. doi: 10.1186/s44158-023-00112-8.

  PMID: 37580838 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank A Rasulo, MD

  Università degli Studi di Brescia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 27, 2023
• Study Start: February 19, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)