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Impact of Two Different Types of Sedation on ICEB

NCT ID: NCT05757063

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-08-01

Brief Summary

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The QT interval is a measure of the combination of cardiac depolarization and repolarization as it encompasses both the QRS complex and the J-T interval. QT, QTc, QTd prolongation or shortening has been associated with ventricular arrhythmias . In order to define non-torsogenic drug-induced arrhythmias, the index of cardio-electrophysiological balance (iCEB), which is a new marker calculated with the QT/QRS formula, has been defined. In our study, we planned to evaluate the effects of dexmedetomidine and propofol on cardiac electrophysiology with all these parameters, especially the newly defined iCEB.

Detailed Description

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Seventy patients who underwent operation under regional anesthesia and received intraoperative sedation will be included in the study. The patients will be divided into two groups, Group D (dexmedetomidine) and Group P (propofol). Sedative agent infusion will be started immediately after spinal anesthesia is administered. Preoperative ASA (American Society of Anesthesiologists) scores, demographic data, comorbidities and medications used will be recorded. Vitals and ECG prior to spinal anesthesia will be recorded. After that, spinal anesthesia will be applied and vitals and ECG will be recorded at 1, 5, 10, 15, 45 and 75 minutes. The sedation levels of the patients will be measured noninvasively by bispectral index (BIS) monitoring. Patients will be kept within the limits of light sedation. The maximum dose of 1.4 micrograms/kg/hour in the dexmedetomidine group (group D, n=35) and 4.5 milligrams/kg/hour in the propofol group (group P, n=35) will not be exceeded. The following parameters were set as the safety endpoint during sedation:

* Respiratory rate ≤8
* SpO2; 95
* Heart rate; 40
* Systolic blood pressure;80 At these endpoints, the patient's sedation dose will be reduced regardless of the BIS value.

During sedation, patients will be given 3 liters of nasal oxygen per minute, which can be increased according to need. Just before and 1st, 5th, 10th, 15th, 45th, 75th minutes after spinal anesthesia systolic arterial pressure, diastolic arterial pressure, mean arterial pressure,peak heart rate, oxygen saturation, bispectral index, QT time, QTc, QT distribution, Tpe, iCEB will be evaluated.

Conditions

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Propofol Dexmedetomidine Electrophysiological Balance Index QT Interval, Variation in Tp-e Interval QT Dispersion Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Propofol

Sedation procedure with propofol

Group Type ACTIVE_COMPARATOR

Sedation with propofol

Intervention Type OTHER

After spinal anesthesia, patients will be sedated with propofol.

Dexmedetomidine

Sedation procudure with dexmedetomidine

Group Type ACTIVE_COMPARATOR

sedation with dexmedetomidine

Intervention Type OTHER

After spinal anesthesia, patients will be sedated with dexmedetomidine.

Interventions

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Sedation with propofol

After spinal anesthesia, patients will be sedated with propofol.

Intervention Type OTHER

sedation with dexmedetomidine

After spinal anesthesia, patients will be sedated with dexmedetomidine.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with ASA Ⅰ-Ⅱ ,
* 18-80 years old, who will be operated under spinal anesthesia

Exclusion Criteria

* Hypersensitivity to the propofol,dexmedotimidine
* preoperative QTc prolongation
* preoperative heart disease
* use of drugs that affect the QT interval
* severe sinus bradycardia
* preoperative electrolyte abnormalities
* liver and kidney function abnormalities
* non-sinus rhythm
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Burak NALBANT

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ICEB

Identifier Type: -

Identifier Source: org_study_id