Effect of Ketamine on BIS Values

• Sponsor: University of Padova (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05288764
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 18.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Brain Monitoring; Ketamine	Device: Bispectral Index

Detailed Description

Correlation between Concentration at the effector site (Ce) of Ketamine and Bispectral Index (BIS) values during general anaesthesia for breast surgery has not been defined yet.

We want to analyze this correlation during general anaesthesia conducted using Propofol, ketamine and remifentanil. All of these drugs will be delivered with Targeted-ControlledInfusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil and Domino for Ketamine).

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Correlation Between Concentration at the Effector Site of Ketamine (Calculated With DOMINO Pump) and Bispectral Index Values During General Anaesthesia for Breast Surgery.
• Actual Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Apr 15, 2022
• Anticipated Study Completion Date: May 15, 2022

Outcome Measures

Primary Outcome Measures

1. Correlation between Concentration at the effector site of Ketamine and BIS values [We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Ketamine values during all the duration of anesthesia, form the start of ketamine bolus until the emergence from anesthesia]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female

Inclusion Criteria:

• Undergo gneral anaesthsia with Targted Controlld Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

• Neurological disease

• Psychiatric disease

• Benzodiazepiones absuntion

• Obesity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ULSS 2 Marca Trevigiana	Treviso	Tv	Italy	31100

Sponsors and Collaborators

• University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Federico Linassi, MD, University of Padova
• ClinicalTrials.gov Identifier: NCT05288764
• Other Study ID Numbers: KetaMAST
• First Posted: Mar 21, 2022
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 31, 2022