Remifentanil Effect-site Prediction by Algometry

NCT05115578 | Completed FDA Drug

• 1 other identifier: EPA (AG) 33/2017 (5097)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study validates the pharmacodynamic analgesic predictions (effect) given by Minto's remifentanil pharmacokinetic and dynamic model in conscious sedation. This standard model is based on the electroencephalogram (EEG) changes induced by this opioid as a proxy for describing the remifentanil analgesic effect, which might be only valid for high concentrations. Validation of the standard remifentanil model for low concentrations under sedation is needed for safer remifentanil administration.

Conditions

Conscious Sedation Failure During Procedure

Keywords

Remifentanil; Algometry; Pharmacodynamics; TCI Infusion system; Conscious Sedation

Outcome Measures

Primary Outcomes (11)

• Pressure pain threshold (PPT) Baseline

  Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry before starting the administration of remifentanil.

  Baseline

• Pressure pain threshold (PPT) 1.5 minutes

  Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 1.5 minutes after starting the administration of remifentanil.

  1.5 minutes

• Pressure pain threshold (PPT) 5 minutes

  Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 5 minutes after starting the administration of remifentanil.

  5 minutes

• Pressure pain threshold (PPT) 10 minutes

  Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 10 minutes after starting the administration of remifentanil.

  10 minutes

• Pressure pain threshold (PPT) 15 minutes

  Measurement of pressure pain threshold(0 - 1.000 kPa) by algometry 15 minutes after starting the administration of remifentanil.

  15 minutes

• Pressure pain threshold (PPT) 18 minutes

  Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 18 minutes after starting the administration of remifentanil.

  18 minutes

• Pressure pain threshold (PPT) 20 minutes

  Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 20 minutes after starting the administration of remifentanil.

  20 minutes

• Pressure pain threshold (PPT) 25 minutes

  Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 25 minutes after starting the administration of remifentanil.

  25 minutes

• Infusion rate

  Remifentanil infusion rate (ml/h) administered during the experiment to the patient provided by the TCI system.

  Continous measurements every 1 second for the whole experiment of 25 minutes

• Remifentanil Plasma Concentration (Cp)

  Patient's remifentanil plasma concentration (ng/ml) evolution during the experiment given by Minto's model implemented in the TCI system.

  Continous measurements every 1 second for the whole experiment of 25 minutes

• Remifentanil Effect Concentration (Ce)

  Patient's remifentanil effect concentration (ng/ml) evolution during the experiment given by Minto's model implemented in the TCI system.

  Continous measurements every 1 second for the whole experiment of 25 minutes

Secondary Outcomes (23)

• Age

  Single annotation.

• Mean arterial pressure (MAP) Baseline

  Baseline

• Mean arterial pressure (MAP) 1.5 min

  1.5 minutes

• Mean arterial pressure (MAP) 5 min

  5 minutes

• Mean arterial pressure (MAP) 10 min

  10 minutes

Study Arms (3)

Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil

Group I of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min.

Drug: Remifentanil 1 MG Injection [Ultiva]; Device: Algometry

Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv

Group II of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min with a bolus of 1 mg of midazolam previous to the remifentanil infusion

Drug: Remifentanil 1 MG Injection [Ultiva]; Drug: Midazolam 1 MG/ML Prefilled Syringe; Device: Algometry

Group III Control

Group III of 30 patients. The same TCI system provided the saline solution in the control group under an equivalent simulation profile to the remifentanil administration

Drug: Saline solution; Device: Algometry

Interventions

Remifentanil 1 MG Injection [Ultiva] DRUG

Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil.

Also known as: Opioid

Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil; Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv

Midazolam 1 MG/ML Prefilled Syringe DRUG

Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv

Also known as: Benzodiazepine

Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv

Saline solution DRUG

Group III Control

Also known as: 0.9% Sodium Chloride Injection

Group III Control

Algometry DEVICE

The algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction.

Also known as: Somedic Type II®, Sweden

Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil; Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv; Group III Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We enrolled 100 female patients scheduled for benign gynaecological surgery. A group of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. The second group of 35 followed the same protocol with a bolus of 1 mg of midazolam previous to the remifentanil infusion to evaluate potential anxiolysis effects. The rest configured to the control group. Algometry was used to quantify pressure pain thresholds regarding basal measurements at time-points of 1.5, 5, 10, 15, 18, 20, and 25 min after induction began beside the blood pressure and heart rate.

You may qualify if:

• Female patients scheduled for benign gynaecological surgery
• years old
• ASA I-III

You may not qualify if:

• Morbid obesity
• Conduct disorder or anxiety-depressive syndrome
• Chronic treatment with psychotropic drugs or opiates
• Pregnancy
• Alcohol abuse
• Documented allergy to remifentanil or midazolam
• Refusal to participate in the study

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Ana Abad-Torrent

Barcelona, 08035, Spain

Location

MeSH Terms

Interventions

Remifentanil; Injections; Analgesics, Opioid; Midazolam; Benzodiazepines; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ana Abad-Torrent, M.D

  University Vall d'Hebron Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: November 10, 2021
• Study Start: March 1, 2017
• Primary Completion: May 15, 2020
• Study Completion: September 30, 2020
• Last Updated: November 10, 2021

Record last verified: 2021-10

Locations

ES (1)