Analgesic Depth Evaluation During General Anesthesia With

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05785273
Study type	Observational
Source	Università degli Studi di Brescia
Contact
Status	Completed
Phase
Start date	February 19, 2019
Completion date	August 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04279054` - Decreased Neuraxial Morphine After Cesarean Delivery	Early Phase 1
Active, not recruiting	`NCT04580030` - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Recruiting	`NCT04099693` - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated	`NCT02481999` - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed	`NCT04235894` - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting	`NCT05525104` - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).	N/A
Recruiting	`NCT05024084` - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth	Phase 4
Completed	`NCT04204785` - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions	N/A
Completed	`NCT03277872` - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope	N/A
Terminated	`NCT03940651` - Cardiac and Renal Biomarkers in Arthroplasty Surgery	Phase 4
Terminated	`NCT02529696` - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Terminated	`NCT03704285` - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting	`NCT05259787` - EP Intravenous Anesthesia in Hysteroscopy	Phase 4
Completed	`NCT02894996` - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?	N/A
Completed	`NCT05386082` - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated	`NCT03567928` - Laryngeal Mask in Upper Gastrointestinal Procedures	N/A
Recruiting	`NCT06074471` - Motor Sparing Supraclavicular Block	N/A
Completed	`NCT04163848` - CARbon Impact of aNesthesic Gas

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms