Effect of Ketamine Infusion on BIS Values

NCT05799729 | Completed DMC

• 1 other identifier: KetainfusionMAST
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this trial is to define if Concentration at the effector site (Ce) of Ketamine, during a continuous infusion and calculated with DOMINO model infusion pump are correlated with Bispectral Index BIS values during general anaesthesia for breast surgery.

Conditions

Anesthesia Brain Monitoring; Ketamine

Outcome Measures

Primary Outcomes (1)

• Correlation between Concentration at the effector site of Ketamine and BIS values

  Discover if there is linear correlation between Concentration at the effector site of Ketamine and BIS values during standard general anaesthesia conducted with Propofol, remifenatnil and ketamine delivered with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia

  Data about Drugs concentration and BIS during general anaesthesia will be collected, in particular BIS and TCI Ketamine values during all the duration of anesthesia, from the start of ketamine infusion until the stop of ketamine infusion(30minutes)

Study Arms (4)

CeK 0.1

Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.1 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated.

Drug: Ketamine

CeK 0.2

Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.2 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated.

Drug: Ketamine

CeK 0.4

Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.4 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated.

Drug: Ketamine

CeK 0.6

Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.1 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated.

Drug: Ketamine

Interventions

Ketamine DRUG

CeK will be set at anesthesiologist's discretion. Only patients with continuous infusion of CeK 0.1, 0.2, 0.4 or 0.6 for at least 30 minutes will be considered.

CeK 0.1; CeK 0.2; CeK 0.4; CeK 0.6

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Authors will recruit patients who will undergo breast oncologic surgery and anesthetized with TIVA-TCI propofol,remifentanil and ketamine anesthesia.

You may qualify if:

• Undergo general anaesthesia with Targeted Controlled Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model)

You may not qualify if:

• Neurological disease
• Psychiatric disease
• Benzodiazepines intake
• Obesity

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IT (1)